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Types Of Rating Methods For Proposals That The Government...
There are two types of rating methods for proposals that the government uses. One is the Numerical
Method and the other is the Adjectival Method. Each method is based off each agencies preference.
The numerical method is quite simple there are categories that can be used to rate such as total cost
and or a combination of cost and non–cost on how the proposal meets the objectives that have been
asking to fulfill. The rating scale is on bias way of being able to objectively provide no favoritism
but use the facts. The scale adds up to 100. For an example it is like a grading rubric that is used on
the grading of papers for universities. Each proposal will have a list of criterias or objectives that
needs to be meant. Next you have a scale of percentages or a number scale that will give each one a
weight to use in the rating part of each objective. Also, it 's common knowledge to list the most
important task first on the proposal and that the vendors should be made aware on how the proposal
will be weighted meaning if cost is more important or a combination of cost and non–cost. This
allows the vendor equal opportunity to be able to tailor the proposal to give them a better chance in
being picked and make the proposal reasonable so no one 's time is wasted. Last, rating method is
adjectival which is a way of rating each proposal on a simple four to five categories. The scale could
be a simple scale that consists of unacceptable, poor, satisfactory, good, and
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Company Structure And Its Types Grounded On Australian...
Introduction:
This report is based on the knowledge about company structure and its types grounded on Australian
standards, the features which different organizations possess while functioning and the obligations
implied on them in light of Australian standards. Secondly the major differences between large and
small companies have also been discussed in this report, that what are those criteria which separate
large companies from small? And the last part discusses the role which the organizations are playing
in the progress of regulation of companies in Australia. The main purpose of these procedures is to
bring uniformity in the regulatory system of Australian companies.
Company Structure:
A company's structure can be either private or ... Show more content on Helpwriting.net ...
Hospitals, schools, old age houses, etc. are few of the examples of organizations which are limited
by guarantee. (Makari, 2005)
3. No Liability Company:
This type of company is only in Australia, specifically for the mining companies. It can be
differentiated by any of the traditional companies their stakeholders are not responsible to pay calls
on unpaid shares. Purchasing of their shares is supposed to bind the shareholders into a binding
contract because of high degree of risk in the business of mining.
4. Unlimited Companies:
Such type of companies formed with or without a shared capital, but the liabilities of the members
are unlimited. At the time of company's liquidation for the payment of financial liabilities the
members of the company are obligated to settle those liabilities.
Proprietary (Private) Companies:
Private companies don't have shares for general public. In case of selling their shares to a new
shareholder requires approval from board of directors and with their mutual consent company's
shares can be transferred to any new shareholder. Such companies are required to have at least one
member up to the maximum limit of fifty members. These companies can be recognized as "Pty
Ltd" in the last of their names.
Private companies are further divided into two types:
1. Small Propriety Company:
There are three conditions implied on these kinds of companies, i.e. Gross Revenue should be less
than $25 Million, Gross Assets are less than $12.5
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The Drug Development And Approval Process
As mentioned in class, as well as in the required Krishna (2008) article, the drug development and
approval process is an extensive and costly endeavor. The goal of experimental medicine is to
increase the efficiency of drug development by providing a better understanding of the drug's
mechanism(s) of action, dose response, efficacy, and safety, allowing the process to be accelerated
for the most promising and efficacious candidates (Krishna, Herman, & Wagner, 2008). Preclinical
testing begins with identifying the ideal drug target. The target should be disease–modifying and/or
have a proven function in the pathophysiology of the disease. Target expression should not be
uniformly distributed throughout the body. There should also be a favorable IP condition allowing
the drug freedom to operate without competition. If the druggability is not obvious a 3D–structure
for the target protein or a close homologue should be available for assessment. The target should
also have favorable 'assayability' enabling high throughput screening. To identify these targets there
are many strategies that can be utilized such as: genomic analysis (phenotype analysis, genetic
association, gene expression profiling etc.), pathway analysis, and activity based proteomic profiling
(Frank & Hargreaves, 2003; Lipsky & Sharp, 2001; Krishna, Herman, & Wagner, 2008). After
conducting extensive animal studies in the laboratory and assessing the safety and biological activity
of the drug compound, the
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Application For Approval Of Project
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCE BANGALORE KARNATAKA
APPLICATION FOR APPROVAL OF PROJECT WORK PROJECT PROPOSAL 1 NAME OF
THE CANDIDATE AND ADDRESS BINA SHRESTHA PADMASHREE SCHOOL OF PUBLIC
HEALTH, NO 23, 80 FEET ROAD, GURUKRUPA LAYOUT, NAGARBHAVI, BANGALORE–
72 EMAILID: bina.shreshamph14@gmail.com 2 NAME OF THE NSTITUTIONPADMASHREE
SCHOOL OF PUBLIC HEALTH 3COURSE OF STUDY AND SUBJECTMASTERS IN PUBLIC
HEALTH4DATE OF ADMISSION TO COURSEOCTOBER 2014 5 TITLE OF THE TOPIC:–
UTILIZATION OF MATERNAL HEALTH SERVICES IN A TARKESHWOR MUNICIPALITY,
KATHAMANDU, NEPAL 6 BRIEF RESUME OF THE INTENDED WORK INTRODUCTION:
Motherhood is a positive and fulfilling experience. But for some women it may be associated with
suffering, ... Show more content on Helpwriting.net ...
Health care delivery system may vary according to the country. In Nepal, Ministry of health and
Population (MOHP) is the main body of health care delivery system. Under the MOHP, Department
of Health Services (DoHS) delivers the entire health care service to the country. The Family Health
Division, one of the divisions of Department of Health Services (DoHS) is responsible for
delivering maternal health care services throughout the country. The division provides the maternal
health services are through sub health posts (SHP) at each village development committee (VDC),
health posts (HP) at each 5 VDCs, primary health care centers (PHC) at each of electoral
constituency, district hospitals at each district, Zonal hospitals at each zone and Regional Hospital at
each region. At community level, there is Village Health Workers (VHW), Female Community
Health Volunteers (FCHV). For outreach areas, outreach clinics are conducted. SHP is the referral
centre for TBAs and FCHVs as well as a venue for community–based activities such as PHC
outreach clinics and EPI clinics. Maternal and child health workers (MCHW) provide antenatal and
postnatal care and assist in–home deliveries whereas Auxiliary nurse midwives (ANM) provide
antenatal and postnatal care as well as delivery at
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The Use Of Biologics And Medical Devices Should Be Strict
The level of regulation governed by the FDA over drugs, biologics & medical devices is a widely
debated topic. In my point of view, the level of regulation on drugs, biologics and medical devices
should be strict. The current regulations governed by the FDA are very strict and should remain that
way because the base of these regulations are underlined by various tragedies which we don't want
to be repeated. For instance, the thalidomide incident in which many children were born with
Phocomelia (shortening or absence of limbs). Thalidomide, which started as an OTC drug in 1957 as
a remedy for sleeplessness was later found to have off–label effects such as mitigation of morning
sickness in pregnant women. Hence was then prescribed worldwide to pregnant women. However,
in 1962 Frances Kelsey prevented the approval of this drug in the USA. This resulted in Harris–
Kefauver Amendment in 1962 which tightened the investigation and approval of drugs requiring the
manufacturers to prove their safety and efficacy. Many incidents could be avoided in the past if the
regulations were firm and so there is an utter necessity of governing bodies for oversight of clinical
trials, new drug development and manufacturing of drugs, biologics and medical devices. Many of
these unfortunate events were mishaps, but there are many such incidents which are the result of
greed and corruption leading to adulteration of drugs, cosmetics and food products. Until the 19th
century the slaughter,
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An Application For Ethical Approval
At the initiation of the project, I signed a research agreement with the Athabasca Denesųłiné Né Né
Land Corporation. The purpose of this agreement was to identify information sharing procedures. It
includes depositing all primary research data in the oral traditions archive of the Athabasca
Denesųłiné Né Né Land Corporation. This agreement facilitated the prior and informed consent to
conduct research with Hatchet Lake, Black Lake and Fond du Lac Denesųłiné First Nations. This
insures that the ownership of the project data remains with the Athabasca Denesųłiné. It also ensures
that all knowledge holders remain anonymous in the dissertation.
The research was conducted under the terms of an application for ethical approval for research ...
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A numeral is associated with each knowledge holder. An additional numeral indicates Individual
interviews. In this dissertation, AD0 identifies knowledge holders, and AD0–0 indicates individual
interviews. Interview notes, recordings, and transcripts remain confidential. These are with the
Athabasca Denesųłiné Né Né Land Corporation. Interviews were in English and Denesųłiné,
assisted with the use of a translator. I vetted all interview data prior to inclusion in the dissertation.
This ensures accuracy and maintains the confidentiality of sensitive information. The vetting process
included opportunities for knowledge holders to expand on interview data. I also shared project
results with communities during public community meetings and one–on–one with knowledge
holders. I used plain language, as well as visual aids, including photos, maps and schematics. I used
translation services when required. This dissertation sparing uses Denesųłiné terms. This approach
better shares Denesųłiné understandings to an English audience. The text explains each Denesųłiné
term as it appears in the dissertation.
Materials reviewed included traditional land use studies. Up–to–date traditional land use
information is in short supply, and much remains confidential. Denesųłiné traditional use
information has been published by Athabasca Chipewyan First Nation (2003a:1–165, 2003b:1–97),
Fort MacKay
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Eversource Seacoast Reliability Project Case Study
The Ury et al. reading explains that a dispute resolution is used to diagnose an existing conflict,
analyze how the stakeholders that are involved will interact and influence each other, and determine
what processes are involved in resolving this conflict. The Eversource Seacoast Reliability Project
(ESRP) requires approval from the Site Evaluation Committee (SEC), which means they must go
through the SEC application and approval process. This SEC approval process in itself is a larger
dispute system used to create an open relationship between the stakeholders as well as ensure that
the developer meets all the requirements in the approval process. The ESRP can be dissected into a
smaller dispute system within this SEC approval process with the main conflict of how to create a
more reliable energy transmission line in the Seacoast area without drastically impacting the unique
environment in the area. This is the main conflict that the proposed ... Show more content on
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I have found some information on the specific technology that will be used to bury the transmission
line under the Great Bay, but I think it is important to understand what specific impacts this process
will have and if there are alternative solutions to using this technology or technique. Many
stakeholders are working on this issue including the Environmental Protection Agency (EPA), but
they have not done an environmental assessment to address this issue. I think I will be able to find
more information as I continue to research the project, but it would be beneficial to all the
stakeholders for the engineering company to produce information pertaining to specific impacts that
this project might cause or even hold a public meeting to further educate the other stakeholders on
their technology and
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Evaluation Of The And Type Approval And Tests
Task Name Part A – MMD_product_development 1.1 Electronics 1.1.1 PCB Design 1.2.Software
1.2.10 R2 Release tests 1.2.11 Error Corrections 1.2.12 R2 Interoperability tests 1.2.13 R2
Interoperability error correction 1.3. Mechanics 1.3.1 Industrial Design 1.3.3 PWB Outline
modifications 1.3.5 Stack Tolerance Analysis 1.4. Verification 1.4.2 Test of Component 1.4.5
Validation tests of Product 1.4.6 File compilation of Technical Construction 1.4.7 Regulatory
approval and type approval and tests 1.5. Build of prototype 1 1.5.1 Lead–time of P1 component
1.5.5 Build of P1 prototype 1.6. Build of prototype 2 1.6.5 Build of P2 prototype ... Show more
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Product From: Manager of the Project Date: December 8, 2014 Subject: Schedule of the Project will
be improved Mr. Product, In the mail below I am connecting the agenda of the project in email for
the orientation and I connect the augmentation of the project. Systematically once computation was
finished it was commence that the conclusion project date is 17/08/2015. On the whole project
duration is 233 days. So, beneath are the features which will origin the long length of the project
which will be linked with task which are dangerous with the project like developments of the
Database and the UI and then the test plan and Project design Review. All tasks which will be
organized and not compulsory to evade any of tasks leave out without the previous one will be
completed and begin the other one, maintaining the dependence of the
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The Drug Development And Approval Process
As mentioned in class, as well as in the Krishna (2008) article, the drug development and approval
process is an extensive and costly endeavor. The goal of experimental medicine is to increase the
efficiency of drug development by providing a better understanding of the drug's mechanism(s) of
action, dose response, efficacy, and safety, allowing the process to be accelerated for the most
promising and efficacious candidates (Krishna, Herman, & Wagner, 2008). Preclinical testing begins
with identifying the ideal drug target. The target should be disease–modifying and/or have a proven
function in the pathophysiology of the disease. Target expression should not be uniformly
distributed throughout the body. There should also be a favorable IP ... Show more content on
Helpwriting.net ...
The main goal in Phase I is to find out if the investigational new drug is safe. In this first phase of
human testing, testing determines the correct dosing and exposes the most common side effects. If
the investigational new drug is found to be safe, Phase II of human testing can begin. The main goal
of Phase II is to find out if the investigational new drug is effective. Unlike in Phase I, the patients
tested in Phase II are not healthy. In this phase, testing determines whether the drug works on
patients it was designed to help. Results are obtained by comparing the group of test patients to
other groups taking a different drug or taking a placebo. Phase III is the first large–scale trial of
human testing. This phase can only begin if the new drug shows to be effective in Phase II. Phase III
seeks to further determine the effectiveness of the drug. This is done by testing the drug on different
populations, meaning that testing will be done on more people, testing will be done with different
drug doses, and the drug will be tested on patients who are also taking other drugs. If Phases I
through III show the investigational new drug to be safe and effective, then the pharmaceutical
company will file a New Drug Application (NDA). The NDA includes both the results of the first
three trial phases and data on how the drug is manufactured (Frank & Hargreaves, 2003; Lipsky &
Sharp, 2001; Krishna,
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Summary: Sharepoint Approval
Iteration 5
SharePoint Approval
The last iteration is the approval of the implemented SharePoint administration technology. The
approval iteration level helps to ascertain the organization needs for the purpose of meeting project
requirements. Before the approval of the SharePoint administrator technology, experts will test the
system to verify if it meets the project needs (Solomon, 2011). Plan
Having developed and installed the new system to the organization, I plan to approve and check on
whether the system operates effectively. I plan to ensure that all configurations, testing, and
checking issues are factors. The move will focus on the selection of the ideal operations within the
company (Arnold, 2012). The experts will work with me during system configuration so as to
ensure that the new SharePoint administrator technology and proposed backup system integrate with
accordance. I plan to check on all components of the system and ensure that they are fixed in
accordance. ... Show more content on Helpwriting.net ...
Such a move was attributed to the fact that, they wanted to prove that the proposed system helps the
company operate more effectively. Senior administrator was more on ensuring that the system
installed was not default in nature. The customization process of the ideal system was put in a
greater focus and that enabled the company gets appropriate information technology system (Diffin,
2010). The company had a suitable information technology system with qualified personnel and its
machines were in the right condition. I observed that the company had an IT expert who oversaw all
the operations carried out by selected team. Use of high–quality equipment within the operations
platform made the management buy the idea of installing the SharePoint administrator technology
system plus the data backup system. The company had all its trust on my advice, training, and
design of the new system (Carr,
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The Latino Political Experience : The Electoral Based And...
Question 3 The Latino political experience, much like the experience of other minority groups, has
been about fighting for inclusion. In order to be included into mainstream society Latinos had to use
different methods to get their grievances heard. In a system that was not designed to benefit
minorities, Latinos had to put aside their differences and come together in order to address to
economic, political, and social marginalization they faced. Due to restructuring and globalization
large segments of the Latino population were excluded from effective economic and political access
and participation. As their numbers increased Latinos began to utilize different methods to address
the changes in their communities. They used two main methods which reflected two conceptions of
empowerment, the electoral based and the household model. The electoral based model is a form of
empowerment that focuses on mainstream electoral politics. It is based on the assumption that the
traditional electoral system is capable of addressing latino issues and having a policy agenda reflects
the interests of latinos. This model use the political system and the use of institutional power to gain
inclusion and recognition in the politics. It is focused on getting greater number of Latinos in office
in order to have representatives who are actually Latino. The goal however, is to gain inclusion into
the existing system instead of reforming it because it fails to give all people equal access. The
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Arguments Against Approval Voting
In the United States, we currently use a system of voting called Plurality voting. Under this system,
each voter is allowed to cast one vote for their preferred candidate. Approval Voting is a system of
voting where are authorized to vote for as many candidates as they "approve" of instead of a single
candidate. As in plurality voting, the most "approved of" candidate wins the election. It is unlikely
that the US will shift from a plurality voting system to an approval voting system because the
approval voting system turns discretionary power from party leaders to the people.
Before the primaries, a presidential candidate was chosen by party leaders. These leaders include
important officeholders and party officials, such as activists who ... Show more content on
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Those with special interests are more concerned about their special interests than the "right" of the
American people. Without campaign finance reform, politicians are beholden to the special interests,
and party leaders along with their special interest groups will continue to want to control elections.
Nonetheless, it is interesting to contemplate how a different voting system might influence elections
and politics if the current regime were changed. In 1977 Guy Ottewell popularized a voting system
called "Approval Voting. Under Approval Voting, voters are allowed to vote for all the candidates
that they approved. By voting for all of the candidates they like, voters do not have to decide who
they like best; they can choose all of the candidates with platforms that are of interest to the voter.
This system mainly favors candidates who voters believe "probably can't win" so they vote for
candidates who they believe "can win" even if they don't like them the best. Approval Voting allows
these supporters to vote for both candidates; they will not be tempted to desert the one who is weak
in the polls as under plurality voting. So, minority candidates tend to receive votes which reflect
their actual level of
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Development Of Generic Product And Approval
Generally, an ANDA sponsor of the topical dermatological product has to undergo multiple review
cycles with the FDA before the product gets approved and the sponsor has to wait for a longer time
mostly. Even though the ICH CTD, ICH Q8 describes the generation of product development report,
it is not still clear to ANDA sponsors how this actually applies. As a result, more internal meetings
and discussions between the sponsors and the FDA delays the product approval. One of the ways to
overcome these challenges is to have a product development report with verified and justified
specifications based on the QbD efforts which can help the Office of Generic Drugs (OGD) to be
efficient in understanding the developed generic product and approval ... Show more content on
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The foremost criteria in developing a generic topical dermatological product is to meet the
pharmaceutical and therapeutic equivalency of the RLD. A therapeutic equivalence is the one which
has the same clinical effect and safety profile as given in the label of the RLD and a pharmaceutical
equivalence is the one which contains identical amount of same active ingredient corresponding to
the same route of administration in the same dosage form with similar mechanism of release and
similar rate and extent of the absorption of the RLD. The current paradigm to get an approval by an
ANDA sponsor is by proving the therapeutic equivalence to the RLD by testing whereas the
proposed QbD approach requires the sponsors to meet the equivalence on the basis of defined
design targets. More specifically, a well–defined rational approach behind each testing is required
for proving the pharmaceutical equivalence and bioequivalence [18].
When talking about the design of equivalence of a generic dermatological topical product, the
criteria for Q1 and Q2. Additionally, in some cases, the Q3 criteria has to be satisfied in addition to
Q1 and Q2 Topical solutions can be stated as an example for Q3. The Q1, Q2 and Q3 may not be a
feasible option if the patent of the RLD is considerably protected. In such cases, the generic
manufacturer may be in a position to look for alternate
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Fda Approval Process Of Drugs Essay
Joston Toney Nicole Thompson English 2010 Online 03 December 2016 The FDAApproval
Process of Drugs When I was a kid, I always wondered why it took so long for an ill person to
become well again. I always thought that if the ill person went to the doctor they would be back to
normal the next day, but that's not the case. For some people it took several days, weeks, months,
and even years to conquer an illness but as a child I never could understand that. I don't know how
many times I've asked my mom or dad how come the doctors don't get together and make a
"miracle" drug that could heal anything and everything. It wasn't until the age of 15 when my
grandmother was diagnosed with breast cancer that I understood why it took so long for others to
heal and the process that they had to endure in order to be healthy again. Shortly after my
grandmother's diagnosis, I started looking into what it would take to get a drug that would cure
cancer through the approval process on the shelf to save some many others just like my
grandmother. But I kept running into a dead end. Everything seemed to keep pointing towards
chemotherapy and radiation. Although I wanted something to heal my grandmother fast,
chemotherapy and radiation was the only solution if I had wish to see her watch me graduate high
school. I went to almost every appointment with her to watch how it helped strengthen but also
watch as it drained her energy. A month of chemotherapy and a few weeks of radiation and my
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Presidential Approval Ratings
The War on Terrorism and Presidential Approval Ratings
With war, there are politics. With politics, there may be war. The perspective of man has a
monumental impact even on the most minuet things to greater issues that affect society as a whole.
Within the realm of politics, specifically the United States, there is democracy in which constituents
choose their representatives. There is a general understanding that these representatives are elected
to provide the best representation and voice of the people; however, the public's opinion and the
responsibility of utilitarianism of the country that the President must consider can sometimes
collide. The rise of Osama Bin Laden and formation of the terrorist group, al Qaeda, with its
terroristic ... Show more content on Helpwriting.net ...
According to data gathered by Hetherington and Nelson using Gallup Polls, President Bush's job
approval rating was 51% the day before the terrorist attack and dramatically increased to 90% by
September 22, which was "the highest rating ever recorded for a president" (2003, 36: 37).
Comparing Gallup Polls taken a month before the September 11 attacks and September 22 reveals
how the rally 'round the flag effect impacted presidential approval from the different political parties
of the United States(Hetherington and Nelson 2003, 36: 39). Hetherington and Nelson's research
shows the changes of presidential job approval rose from 89% to 98% among Republicans,
Independents increasing from 53% to 91%, and approval among Democrats jumped from a dismal
28% to 84% (2003, 36: 39). President Bush used this surge in approval ratings to help his fellow
Republicans win seats in the November 2002 midterm elections, ultimately taking control of both
the House of Representatives and Senate (Hetherington and Nelson 2003, 36: 42). On September 14,
2001 President Bush visited ground zero and addressed rescue workers with a bullhorn in a
passionate and unscripted speech that resonated with Americans. Several members of the audience
shouted that they could not hear President Bush. The President responded with "I can hear you. The
rest of the world hears you. And the people who knocked down these buildings will hear all of us
soon" (Gregg 2003, 32: 145). Soon thereafter President Bush received near unanimous support from
both houses of Congress when they passed a joint resolution giving the president permission to use
"all necessary and
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[unused38]on's Moral Sense, By Hutcheson And Shaftesbury
Hutcheson and Shaftesbury believed that human nature contained all it needed to make moral
decisions, along with inclinations to be moral. Moral sense is a kind of sense because, like external
senses, it is common to all mankind. It is independent of our will and its deliverances are not
conclusions mediated by premises. In particular it is not mediated by considerations of personal
advantage or harm. It is on account of this feature that we are able to admire actions that took place
in remote times and regions and even actions that are contrary to our own interests .
Moral philosophers say that the main contribution of Hutcheson to the concept of moral sense is that
he describes the working of moral sense. The process, Hutcheson described, ... Show more content
on Helpwriting.net ...
Approbation of our own action is given when we are pleased with ourselves for doing the action
and/or pleased with our intentions for doing the action. Hutcheson puts it this way: "Approbation of
our own action denotes, or is attended with, a pleasure in the contemplation of it, and in reflection
upon the affections which inclined us to it" . Consider what happens when someone picks up and
returns something that another person drops. In response to the action, the person who picked up the
dropped item would have feelings of approbation toward his own action. This person would be
happy with what he did, especially after giving it some thought. Further, they would be pleased if
their own intentions were ones with which they could also be pleased. The intention could possibly
be that they just wanted to help this person; however, if the intention was to gain advantage with the
other person, then they would not be as pleased with themselves. Approbation of another's action is
much the same except that the observer is pleased to witness the action of the other person and feels
affection toward the agent of the action. Again Hutcheson writes: "Approbation of the action of
another has some little pleasure in attending it in the observer, and raises love toward the agent, in
whom the quality approved is deemed to reside, and not in the observer, who has
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The Drug Development And Approval Process
As mentioned in class, as well as in the Krishna (2008) article, the drug development and approval
process is an extensive and costly endeavor. The goal of experimental medicine is to increase the
efficiency of drug development by providing a better understanding of the drug's mechanism(s) of
action, dose response, efficacy, and safety, allowing the process to be accelerated for the most
promising and efficacious candidates (Krishna, Herman, & Wagner, 2008). Preclinical testing begins
with identifying the ideal drug target. The target should be disease–modifying and/or have a proven
function in the pathophysiology of the disease. Target expression should not be uniformly
distributed throughout the body. There should also be a favorable IP condition allowing the drug
freedom to operate without competition. If the druggability is not obvious, a 3D–structure for the
target protein or a close homologue should be available for assessment. The target should also have
favorable 'assayability' enabling high throughput screening. To identify these targets there are many
strategies that can be utilized such as: genomic analysis (phenotype analysis, genetic association,
gene expression profiling, etc.), pathway analysis, and activity–based proteomic profiling (Frank &
Hargreaves, 2003; Lipsky & Sharp, 2001; Krishna, Herman, & Wagner, 2008). After conducting
extensive animal studies in the laboratory and assessing the safety and biological activity of the drug
compound, the
... Get more on HelpWriting.net ...
Marketing Approval For Medicinal Products Essay
There are accelerated pathways in different countries to make available new therapy for their
patients, who have unmet needs. The USA, UK and Japan are offering an accelerated marketing
approval for the medicinal products. USA: USFDA is offering a Fast Track, Breakthrough Therapy,
Accelerated Approval, and Priority Review options to expedite the medicinal products approval.
Fast Track designation – drugs that treat serious illnesses and fulfill unmet medical needs,
manufacturer gets more support and advice from the FDA to accelerate the approval process.
Breakthrough Therapy – medicinal product that supports unmet need and shows important benefits
over existing drugs gets fast track designation, and gets more intensive guidance from the FDA.
Accelerated Approval process –drugs that fulfill an unmet need in a serious condition, and that can
establish an effect on a substitute indicator or intermediary clinical endpoint can get early approval
before providing full clinical data, but company has to make a commitment to conduct phase IV
confirmatory trials (FDA, 2016). Priority Review –Approval process time reduced from 10 months
to 6 months. UK: In the UK, the early access medicine scheme introduced in the year 2014 for the
purpose of allowing patients who suffer from life threatening or serious worsening medical
conditions to access the medicines that did not get yet a marketing authorization. An application of
Promising Innovative Medicines (PIM) to the MHRA (Medicines
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The Quality Of A Person 's Relationships With Their...
This research is designed to answer the following question: Does the quality of a person's
relationships with their parents and with their peers influence the extent to which that person
engages in marijuana use? "Data for this study come from the [seventh wave of the] National Youth
Survey (NYS). The NYS is a nationally representative, longitudinal survey of 1,725 U.S. youth
between the ages of 11 and 17 at the time of the first interview in early 1977. Respondents were
interviewed annually through 1981 (Waves 1–5) and then again in 1984 (Wave 6) and 1987 (Wave
7). By the last wave of interviews, respondents were between the ages of 21 and 27 years" (King &
South, 2011, p. 107). The variables used consisted of two independent variables, Perceived
Disapproval by Parents Towards Deviance and Perceived Disapproval by Peers Towards Deviance,
and the dependent variable of Marijuana Use. The variable Perceived Disapproval by Parents was
operationalized by creating a composite variable from the following questions: "PARENTS OPIN:
CHEAT ON INCOME TAX (Y7_378), PARENTS OPIN: STOLEN WORTH <$5 (Y7_379),
PARENTS OPIN: SOLD HARD DRUGS (Y7_380), PARENTS OPIN: USED MARIJUANA
(Y7_381), PARENTS OPIN: STOLE WORTH >$50 (Y7_382), PARENTS OPIN: HIT SOMEONE
(Y7_383), PARENTS OPIN: DESTROYED PROPERTY (Y7_385), PARENTS OPIN: BROKE
INTO VEHICLE (Y7_386), PARENTS OPIN: DELIB HURT SP/PARTN (Y7_387)" (National
Youth Survey [United States]: Wave VII, 1987). The composite variable was created by taking
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The Drug Approval Of The Disease Essay
There are over 7,000 rare diseases affecting between 25 and 30 million Americans (Global Genes
2016). A disease or disorder is defined as rare in the U.S when it affects fewer than 200,000
Americans at any given time (Eurordis 2016). Some of these rare diseases come with even more rare
and controversial decisions. "The FDA just made its most controversial drug approval of the year"
(Fortune 2016). This injectable drug is called eteplirsen by Sarepta Therapeutics and it is an exon–
skipping drug targeting a section of genetic code called "exon 51" in the dystrophin gene. Exon
skipping is a type of strategy that is being developed for the rare disease DMD (Duchenne Muscular
Dystrophy). The exon–skipping process skips sections of genetic codes during protein
manufacturing, allowing cells to create shortened but partially functional dystrophin protein which
is the muscle protein that is missing in DMD. This rare X–linked disease was first described in the
1850's by French neurologists Guillaume Duchenne but was not known to inhibit the production of
protein dystrophin and result in the loss of motor functions and muscular degeneration until the
1980's (MDA 2016). 1 in 3600–6000 live male births has resulted in DMD (Bushby 2010). Most
patients are diagnosed around 5 years of age when their physical abilities are no longer similar to
their peers (Bushby 2010). If left untreated, signs of deterioration in muscle strength increase, the
chance of using a wheelchair before their teens
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Corporate Law And Shareholder Approval
Most equity carve–outs do not require shareholder approval and require only approval by the parent
company's and subsidiary company's boards of directors. More complicated corporate law
considerations, particularly those related to fiduciary duties, typically arise following the closing of
an equity carve–out, especially if the parent retains a significant equity interest in the subsidiary.
Shareholder Approval
The question of whether shareholder approval is required to implement an equity carve–out is
determined by state law. While shareholder approval statutes vary by state, most are substantially
similar to Delaware's statute, which provides that shareholders must approve a transaction in which
a company will sell all or substantially ... Show more content on Helpwriting.net ...
Most equity carve–outs are not large enough to require shareholder approval; if the parent sells less
than a majority stake and retains control over the subsidiary, there is a strong argument against
needing to obtain shareholder approval. If the parent sells between 50% and 100% of its subsidiary
shares, on the other hand, and the subsidiary's business is important to the parent, there is a strong
argument in support of needing shareholder approval. The requirement for shareholder approval is
significant because proxy materials must be mailed, a shareholder meeting must be organized and
approval must be obtained before the transaction can be completed. If the parent's shares are
registered under the Exchange Act, proxy materials must comply with Regulation 14A and meet
disclosure requirements. While proxy materials should disclose the material terms of the offering,
details such as final price and size of the offering are typically not determined until the registration
statement is effective, which creates a risk that the parent will not be able to meet its disclosure
obligations.
Board Approval
Approval is typically required by both the parent's and the subsidiary's boards of directors in order
to implement an equity carve–out. While the specific
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Quality And Safe Product Approval System
1. Objective
To undertake a critical review of the current product check and release processes to ensure a robust,
high quality and safe product approval system is in place to safeguard patient safety and to ensure
compliance with standards and recommendations.
2. Background
The aseptic preparation of products at Northern Lincolnshire and Goole NHS Foundation Trust
(NLAG) is carried out in an unlicensed unit under Section 10 exemption of the Medicines Act 1968.
(1) It requires that the preparation is done by or under the supervision of a Pharmacist, who takes
full responsibility for the quality of the product.
Until recently, in unlicensed units working under Section 10 exemption, even if the final checks
were carried out by ... Show more content on Helpwriting.net ...
It provides a proposed product approval/Pharmacist supervision model that has been attached in
Appendix 1.
Final product accuracy check and release at NLAG is undertaken by the Authorised Pharmacist
(usually band 7 or above). The Authorised Pharmacist also undertakes the clinical checks/screening
of the prescriptions. It has been discussed that undertaking these checks by different pharmacists
will add an extra safety check in the process and there is a plan for separation of these roles in the
near future. The plan is to have a Clinical Pharmacist undertaking the clinical checks in the clinical
area and an Authorised Pharmacist in the Aseptic Unit undertaking the product check and approval
(release). Another proposal has been suggested following this analysis.
There are some concerns regarding separation of the roles as the staff who may be involved in
approving products (band 6 pharmacists) have a lack of knowledge and skills in aseptics. There is
also a need for cost effective working and flexibility within the service, including appropriate skill–
mix. This all emphasises a requirement for this critical analysis to ensure that a robust product check
and release is undertaken.
Although errors in the preparation of injectable medicines within pharmacy aseptic environments
are not very
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Tattoos : Self Expression Or Approval?
Tattoos: Self Expression or Approval? Ink that is normally used on paper is submerged into layers of
my skin. While staring at the permanent feature, I wonder was this a way of me expressing myself
using my body, or the approval of myself and others? At the age of fourteen, preteen girls are
normally focused on buying the latest purses or shoes, but that was not the case for me. Throughout
my first year of high school my mind was solely set on getting a tattoo. Being so young, my mother
was very hesitant to allow me to permanently ink my skin. However, when I was ten, I went against
my mother's word by getting my second hole on my ears pierced even after she advised against it.
Knowing my determination in getting the things I want, she made a deal with me. The deal being
that I had to take a full year to consider the tattoo and if I was still fixed on it she would allow me.
As the year passed, I had only one idea in mind that never changed. I wanted the tattoo to be
meaningful and something I would not regret. The idea of this being permanent, unchangeable, and
forever on my skin for the rest of my life was fearful. Growing up my mother had sayings for my
brother and I that was written in every text and inscribed in every card. "Stay Sweet", two words
that have been engraved in my head since before I could speak. It was clear, without hesitation, that
I was ready to have these words also engraved in my skin. Almost four years later and I wonder
what did this small form of
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The Drug Development And Approval Process
As mentioned in class, as well as in the required Krishna (2008) article, the drug development and
approval process is an extensive and costly endeavor. The goal of experimental medicine is to
increase the efficiency of drug development by providing a better understanding of the drug's
mechanism(s) of action, dose response, efficacy, and safety, allowing the process to be accelerated
for the most promising and efficacious candidates (Krishna, Herman, & Wagner, 2008). Preclinical
testing begins with identifying the ideal drug target. The target should be disease–modifying and/or
have a proven function in the pathophysiology of the disease. Target expression should not be
uniformly distributed throughout the body. There should also be a ... Show more content on
Helpwriting.net ...
The main goal in Phase I is to find out if the investigational new drug is safe. In this first phase of
human testing, testing determines the correct dosing and exposes the most common side effects. If
the investigational new drug is found to be safe, Phase II of human testing can begin. The main goal
of Phase II is to find out if the investigational new drug is effective. Unlike in Phase I, the patients
tested in Phase II are not healthy. In this phase, testing determines whether the drug works on
patients it was designed to help. Results are obtained by comparing the group of test patients to
other groups taking a different drug or taking a placebo. Phase III is the first large–scale trial of
human testing. This phase can only begin if the new drug shows to be effective in the phase II.
Phase III seeks to further determine the effectiveness of the drug. This is done by testing the drug on
different populations, meaning that testing will be done on more people, testing will be done on
different drug doses, and the drug will be tested on patients who are also taking other drugs. If
Phases I through III show the investigational new drug to be safe and effective, then the
pharmaceutical company will file a New Drug Application (NDA). The NDA includes both the
results of the first three trial phases and data on how the drug is manufactured (Frank & Hargreaves,
2003; Lipsky & Sharp, 2001;
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Approval Of The Institutional Review Board
Prior to the conduction of this study, the researcher sought the approval of the Institutional Review
Board with the Protection of Human Subjects in research. The researcher completed re–certification
with the Institutional Review Board training on May 29, 2014 (See Appendix C). The researcher
provided IRB with information such as research protocol, interview protocol, Demographic
Questionnaire, researcher's background information, consent form, and investigator's assurance.
Upon IRB approval, the research contacted the contacted the Superintendent of each school district
for their permission to conduct the study in their districts. Next the principals of the schools were
contacted for their permission to interview teachers in their building. At this point, the research was
able to contact the participants for an interview. The Principals, after permission was given for the
study, were asked to provide the participants e–mail addresses and phone numbers. In this
qualitative phenomenological research, the researcher went to the building that the participants'
schools were located for participants' convenience. The researcher followed a protocol of first
conducting individual interviews with each of the ten participants. A semi–structured, conversational
style of individual interviewing was adopted in order to explore the respondents' stories which made
interviewing multiple subjects more methodical (See Appendix A for Interview Protocol). According
to Meehan, 20014),
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Common American Pizza Essay
In 1905 the United States of America hit an incredible milestone. The first pizzeria was opened in
Manhattan, called Lombardi's. Since that glorious day American's have enjoyed the delicious taste
of pizza. Pizza is a world–wide food that is savored in many countries across the globe. It was first
created in Naples, as an inexpensive food for un–wealthy common folks. It started out as flatbreads
topped with assorted fixings like cheese, oil, tomatoes, and garlic. Pizza has evolved over time into
what we know it as today. Popular toppings on the common American pizza are sausage, pepperoni,
cheese, veggie, and bacon. It would be interesting to see which of the five options would be the
most popular and which option would be the least popular. ... Show more content on Helpwriting.net
...
This method is carried out in different rounds, where one pizza topping will be dropped after each
round. The pizza topping that has the fewest first place votes gets eliminated. When there are only
two pizza toppings remaining the topping with the most first place votes is the winner of plurality
with elimination. I created a table to show the results of the different rounds. The table is similar to
the preference chart, but the rows are only showing the first place selections. It is important to
understand that whenever a pizza topping gets eliminated it is taken out of the order. The pizza
topping that was directly below the one that got eliminated will move up in the order. For example,
the first round bacon got the least amount of first place votes. Therefore, bacon was eliminated and
anything below bacon was moved up in ranking. So if the order was bacon, sausage, pepperoni,
cheese, then veggie the order would change to sausage, pepperoni, cheese, then veggie to
accommodate the fact that bacon was eliminated. Looking at the second round on the chart, the
orders changed significantly as well as the scores. In the second round, veggie got eliminated
leaving pepperoni, sausage, and cheese still in the running. In the third and final round pepperoni
was eliminated. The pizza topping that had the most first place votes after eliminating pepperoni
was
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Ethical Approval Form For Undergraduate Projects
DIVISION OF PSYCHOLOGY & COUNSELLING, UNIVERSITY OF HUDDERSFIELD
ETHICAL APPROVAL FORM FOR UNDERGRADUATE PROJECTS
Part One
Project Title Hot or not ? Assessing changing social attitudes to body image and attractiveness
through a study of TV advertising
Student name Pandora Papamichael
Supervisor name Christopher Bale
Date
Yes No N/A
1 Will you describe to participants what will happen in your study (e.g. experimental or interview
procedures) in advance, so that they are informed about what to expect?
2 Will you tell participants that their participation is voluntary?
3 Will you obtain written consent for participation?
4 If the research is observational, will you ask participants for their consent to being observed? ...
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YES NO N/A
9 Will your project involve deliberately misleading participants in any way?
10 Is there any realistic risk of any participants experiencing either physical or psychological
distress or discomfort? If Yes, give details in part three of this form, and state what you will tell
them to do if they should experience any problems (e.g. who they can contact for help).
11 Does your project involve work with animals?
.
12 Do participants fall into any of the following special groups? If they do, please refer to the
guidance notes and provide the justification required in part three
Prisoners, children (under 18), NHS patients, NHS staff, Social Services clients and other vulnerable
adults. 13 Are there any threats to your safety (either physical or psychological) in carrying out this
research?
If you have ticked Yes to any of Q9–12, please make sure you give an explanation on Part Three of
the form. You do not have to complete Part three I fyou have answered NO to all questions.
There is an obligation on the student to bring to the attention of the module leader any issues with
ethical implications not clearly covered by the above checklist. Part Two
In this section you need to provide more details about your project. Please complete the table below.
Project title Hot or not ? Assessing social attitudes to body image and attractiveness through a study
of TV advertising
Project aims/ hypotheses To see how people feel about
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Project Rfp And Bids Approval
1. CR Status
Project RFP/Bids CR Status
Mezzanine Bids Received Approved
Pump House Bids Received Approved
Snow Melter Approved
Micro Turbine Approved
SMG Pump and Boiler Skids Bids Received Approved
SMG Mechanical / Electrical Approved
SMG Plumbing CRs in process
Big House Columns Bid Received Approved
Summit BOS Facility Approved
2. Waste Heat and Fuel Piping Discussion – CPS met with NSF, ALEX and CRREL on Jan 27th to
discuss the proposed plan. Notes and a site plan for the buried lines at Summit are attached for
review (Attachment A).
B. Raven
1. Raven Camp CR – CPS is waiting for direction from NSF to submit this CR. Has there been any
discussions with AIL? Should this CR be submitted?
2. Raven Power System Options – CPS has ... Show more content on Helpwriting.net ...
Action Items:
1. CPS (Sever) to check with IAB if any permits are required from BLM for the USDA Labs to be
installed at Toolik. The permit is based on the Toolik LRFP, which will be updated for IAB to
provide to BLM. CPS has started the process of updating the LRFP document. Ongoing
2. CPS (Smith) to develop an estimate of the long term maintenance costs of the BEO power line.
UIC is working with AK Line Builders to obtain pricing. Ongoing
3. CPS (Raine/Burnside) to develop a list of assets required for the GrIT and SCAT to help define
"what is" GrIT and SCAT. Ongoing
4. CPS (Sever) to develop a final report of the SMG Fabrication, including costs and weights. This
will be used to assess similar structures in the future and to share with AIL. Include info on the pull
test performed by CRREL. Ongoing
5. CPS (Timmons) to develop an estimate for a new Summit Utilidor. NSF has proposed changing
the concept for Summit to elevated structure eliminating the need for the Utilidor. This actions item
is overcome by events, recommending closing. Complete
6. CPS (Jay/Jessy) to develop an analysis of vehicle usage for Thule and provide a recommendation
on lease vs own. CPS has revised the paper and a final version will be provided for review. Ongoing
7. CPS (Burnside/Wahl) to assess all equipment to determine if there are outstanding recalls and
develop a process to do this annually. Jeff has started this process. Ongoing
8. CPS
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FDA's Approval of Prescription Drugs Essay
There are many direct to consumer advertising for prescription drugs. On television, magazines,
radio etc, you see the most recent advertisements for prescription drugs. After some people see the
advertisements they soon rush over to their doctor and their illness and life would be perfectly pain
and stress free. Making the public conscious of options for treatment is not a bad thing. But these
false advertisements are misleading consumers onto unnecessary treatment. Advertisements have
one primary purpose that is to persuade. Prescription medications Ads tell the consumers to get
treatment and also imply that they have the need for it to solve their problems. Since prescription
Ads have been introduced, the pharmaceutical ... Show more content on Helpwriting.net ...
Merck will soon face many challenges in the business of producing drugs. The company's most
popular drugs are coming to a close to their patent expiration. One of the best selling drugs is called
Zocar, which is used for cholesterol problems. Zocar will have to soon face competition next June
from other generic drug makers. The elimination of Zocar from the market will erase the $5.2 billion
sales annually. Fosomax, an osteoporosis relieving drug, produced by Merck will soon lose the$ 2.2
billion annual sales because of the expiration of its patent. Also, another problem is the struggles
recently to find new medicines. The prescription painkiller drug, which was introduced in 1999, is
called Vioxx. Vioxx was introduced by Merck and co. Vioxx served the purpose of being a painkiller
in the relief of osteoarthritis, rheumatoid arthritis, painful menstruation and other types of acute
pain. This painkilling drug would be classified as a non–inflammatory drug (NSAIDs). Last year, in
September 2004, Merck withdrawed Vioxx, off the market. Studies of Vioxx showed that it doubled
the risk of a heart attack or stroke for patients who have used it more than 18 months. After Merck,
withdrawed Vioxx from the market, the FDA, issued a public health advisory for the users of Vioxx.
Therefore, Vioxx was on the market for five years without
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Importance Of Approval In Nursing
Topic approval
Summary: in the unit where I work there are approximately 8 to 12 doctors, and 2 nurse
practitioners writing orders on any given day. Each of these providers have their own template that
they use to chart in the patient's chart that automatically populates most of the information to fill out
things like there H&P. An interesting issue is that of all these providers none of their templates are
the same. They have shared with one another, and then customized to suit their individual
preferences. But none of them have a template that addresses all the requirements needed to justify
and/or support any orders that they may submit to be processed. This causes the patient to have the
expectation that whatever the physician has promised ... Show more content on Helpwriting.net ...
This ultimately ends up with the patient not receiving what the doctor had promised on the 1st visit
to have ordered. The patient never blames their insurance company but blames the facility that I
work for. My approval plan is to simply have an insert to put into all the physicians templates a
small clause that would require the physicians to address all the reasons that any order would be
denied. This will save at least 4 personnel from attempting getting approval for orders that they
know have not met the insurance requirements. To do this it will take a lot of collaboration with all
the providers to be willing to take a few extra steps, or to at that point tell the patient that you must
do this (physical therapy) for example before your insurance company will prove the order that I
suggest. This will either require the patient to fully comply with the requirements or prerequisites of
their insurance company, and if they choose not to, then it can be explained that this order will not
be approved and we will not submit it until all the requirements are fulfilled. This will save many
man–hours that we are currently devoting this task knowing that it will fail. As well as not setting
the patient's expectations for something that we know will
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The Drug Approval Process Essay
The drug approval process is a complicated labyrinth that sometimes seems impossible to navigate.
There are guidelines, protocols, procedures and standards that each person in the process are
expected to follow. This includes the doctors, principle investigators, researchers, pharmaceutical
companies, the regulatory bodies and yes, the patients. The patients are by far the most important
aspect of a clinical trial and obtaining drug approval. Without the willing volunteers in clinical trials
there would not be treatments and cures for many diseases today. There are a lot of factors that go
into getting a new medication to the open market, including many phases of clinical research. The
roles of the FDA, various research laboratories and the pharmaceutical companies all play a pivotal
role in the time that it takes to obtain drug approval. There are many obstacles associated with each
step including funding and how that impacts the consumer costs.
Our country began with no limitations on goods and quickly progressed to enforcing accurate
labeling and mandatory testing. This has advanced to enforcing challenging scientific standards,
which tend to be somewhat controversial today. The years between 1938 and 1951 are pegged "The
birth of the modern pharmaceutical trade: the Revolution in medicine" according to Philip Hilts
(2003). The industry went from just a few chemical companies to an explosive initiative to discover,
develop and market drugs at a rapid pace. This was
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Increasing the Approval Ratings for President Obama
"What Should I do To Increase My Approval Rating?"
Introduction
When my iPhone said "The White House" I thought it was the local restaurant I had made
reservations over the weekend for my parent's anniversary. There was a very stern voice that said
"President Obama needs your opinion on the current approval ratings, please hold for the President
of the United States of America"¦and we thank you for your service"¦" Wow! President Obama
wanted advice on how to improve his approval rating. I laid out my three point plan I have long
been advocating throughout the debates (I have had with my family and friends).
Three Point Plan to Increase Approval Ratings The most critical area of President Obama's approval
rating has to do with the economy. To get America back to work as quickly as possible I proposed he
immediately create new venture economic opportunity zones throughout the U.S., concentrating on
those areas hardest hit by the recession. I'd focus specifically on Ohio, which has lost hundreds of
thousands of jobs. My plan would be to roll out entrepreneurial assistance to new ventures with a
solid business plan, and also a strong management team. Creating and fostering entrepreneurialism
is critical for the overall successful functioning of a complex economy such as the U.S. (Trimi,
Berbegal–Mirabent, 463). I would tell him that he also needs to become known as the
Entrepreneurial Candidate, concentrating on small business and immediately removing the many
barriers
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Kennedy V Nsw Minister For Planning
CASE NOTE: KENNEDY V NSW MINISTER FOR PLANNING [2010] NSWLEC 129
I INTRODUCTION
In this case, Kennedy v NSW Minister for Planning [2010] NSWLEC 129 the plaintiff is identified
as Roy "Dutch" Kennedy on behalf of Sandon Point Aboriginal Tent Embassy and the defendant is
the NSW Minister for planning . The case was heard in the NSW Land and Environment Court by
Justice Biscoe. The applicant is lodging a review, and thus challenging the grounds of the original
decision in relation to the legality of an administrative decision by the Minister for the Stockland's
Developments Pty Ltd.
II MATERIAL FACTS
The Sandon Point was considered a potential State Significant site under the State Environment
Planning Policy (Major Development) 2005. In April 2006, the Minister authorised Stockland and
Anglican Retirement Villages to submit a concept plan for the development of Sandon Point,
Wollongong. The concept plan was approved in December 2006. In November 2007 the Minister's
approval was challenged in Walker v Minister for Planning [2007] NSWLEC 741, 174 LGERA 127
due to the Minister's failure to take in to consideration the principles of ecological sustainability,
specifically, climate change and flooding. The Court of Appeal found the Minister guilty of failing
to consider public interest in the concept planning stages and made it mandatory to be considered in
the development approval stage.
In mid–2008, an amended concept planning including additional climate change information
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Quote Approval In Interviews
The practice of quote approval in interviews with politicians and their campaign officials is
becoming more common as the constant need for information allows sources to dictate the terms of
interviews. Case study 2–A presented by Patterson & Wilkins (2014, p. 37) is concerned with the
ethical implications of allowing government officials use quote approval in their interviews and how
quote approval affects the reliability of information. Quote approval is a practice that is relatively
harmless when omitting parts of quote doesn't change its meaning, but quote approval also sets a
dangerous precedent that could lead to more governmental control over public information and the
press.
Micro Issues First, journalists need to provide citizens ... Show more content on Helpwriting.net ...
The freedom of expression is granted unconditionally on the grounds that it is used to do moral
good, and placing the needs of a few politicians over the general public is not morally good
(Patterson & Wilkins, 2014, p. 38). Bending the truth to benefit the campaign or image of a public
figure is deceiving the public regardless of the information being withheld. Citizen journalism
heavily influence quote approval since many politicians have misspoke when speaking "off the cuff"
with citizens and damaged their public image. Quote approval is used to assure that these situations
do not occur and hurt polling numbers, but quote approval could be considered to be breaking the
ethical news values of accuracy and community (Patterson & Wilkins, 2014, pp. 35–36).
Conclusion
In conclusion, quote approval can blur the lines between ethical and unethical journalism depending
on the degree of alteration to a quote. Altering quotes can be ethical if it only makes the quote more
concise and easy to understand, but there is a fine line between altering for readability and altering
the meaning. Quote approval is a slippery slope that could lead to public figures and government
officials controlling the flow of information, and the implications of a news media controlled by the
government are extremely
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Task 2 Approval (PEP)
3 weeks of voluntary work until PEP Task 2 Approval (17th March – 6th April) 300 working hours
of PEP (during semester 1, winter break, semester 2, 2016) Although I set working hours whilst on
PEP, sometime I was required to be flexible with the time schedule to complete some tasks sooner
for further processing, and this definitely challenged me especially during the assignment week at
uni. For instance, if someone from the Mind Smart Guides Focus Group couldn't attend a session, I
still needed to reschedule with him or her individually to cover his/ her task. However, this even
turned out to be a good opportunity to interact with group member(s) personally, which lead them to
be more engage freely with the research investigator beyond
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Pros And Cons Of School Board Approval
Enterprise City Schools has a simple hierarchy regarding the structure of the Enterprise High
School's Athletic Department. All major decisions require school board approval. However, Some of
the day to day decision need only the approval of the principal or athletic director. The school board
meets once a month on the third Tuesday of every month. Requiring all major decisions to have
school board approval has its pros and cons. One major pro is coaches, the administrators must be
organized and play proactively to get things accomplished. A con is that a decision may take a
month to get made. The best way to differentiate between what decision require whose approval is if
the school is required to sign a contract, it will need school board
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Application For Approval Of Research Activity
14.1. Appendix I – Application for approval of research activity RAD Form APPLICATION FOR
APPROVAL OF RESEARCH ACTIVITY RETURN the completed form to Jeanette Fifield,
jfifield@eit.ac.nz 1. Applicant details 1.1 Name of Applicant(s) Manu Jacob Iype 1.2 Position of
Applicant(s) Student 1.3 School and Faculty School of Computing, Faculty of Business and
Technology 1.4 Contact Phone 0223951712 1.5 Supervisor (if applicable) Prof. Alison Clear 1.6
Project Title Green Cloud Computing 1.7 Project Start Date and Duration 21st March 2016, 15
Weeks 2. Research Outline 2.1 Aims/objectives/hypotheses of project (describe in plain language,
free from jargon) The aim of this research is to study the contributions of green cloud computing in
reducing the wastage of energy and the operational cost in datacentres hosting cloud services and
thereby acquiring the environmental sustainability. The study also considers the benefits that can be
gained by both service providers and users by having their services going green. The research focus
on achieving the result through different case studies done on the performance of network devices
and hardware's with and without going green. 2.2 Participants (include information on the
participant population, inclusion and exclusion criteria, number and age range of participants,
method of recruitment and any payment or reward offered) NA 2.3. Explain the data collection
methodology (submit questionnaires, interview / focus group
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Application Of Planning Approval And Building Permit
Since the proposal is required to apply for a change of use on land, from dwelling to a food and
entertainment area, the Local Council of the City of Cockburn needs to grant a planning approval
and building permit is to be issued before any use and construction work are to commence. The
proposal of a dwelling area to be redeveloped as a new tavern or restaurant with an outdoor
entertainment area requires being in the correct zone to avoid being deemed of refusal by the
Council. According to the Town Planning Scheme No. 3 (TPS 3) of the City of Cockburn (City of
Cockburn 2014), the permitted zones found on the Scheme map are to be in the Regional Centre,
District Centre, and Light and Service Centre.
Planning Approval Process
A planning ... Show more content on Helpwriting.net ...
The MRS Form 1 is a request form to start development for the Local Council to evaluate and
inspect the proposed development.
Additionally, a copy of Certificate of Title with Diagram and Strata Plans are also to be submitted
with the approval form. These could be acquired through the Landgate website of the Government
of Western Australia (www.landgate.wa.gov.au). The Certificate of Title distinguishes the property
ownership, survey plans, and any notices and warnings against the title (West Australian Land
Information Authority 2015). A Strata Plan covers the sketches of the building, lot sizes, title details,
unit entitlement and common property, and any notices and warnings over the property (West
Australian Land Information Authority 2015). It would be easiest to order online through the
Landgate website with a cost of $24 for both (West Australian Land Information Authority 2015).
The only details needed to order are: the street address, lot number, or title number, a debit or credit
card, and an email address (West Australian Land Information Authority 2015).
Another requirement is a full written account, which includes a detailed development of the
proposed development of the building, a justification of the change of use on the building, and a
compliance agreement with the City of Cockburn TPS 3, Residential Design Codes,
... Get more on HelpWriting.net ...
FDAApproval Process
FDAApproval Process It is commonly documented that every drugs and medical devices brings
some risk or side effects. As a matter of fact, every year roughly approximately 1–2 drugs and 6–8
medical devices are discontinued from the U.S. market because of safety issue. Nevertheless, the
FDA is charged with assessing the protection and value of medical devices and drugs assessing the
advantages versus danger of every merchandise. Nonetheless, the FDA authorization procedures that
are utilized for drugs and devices may vary extensively through the CDER. For instances the drug
expansion program, takes about anywhere from 8 to 10 years, and starts with a few pre–clinical
studies that evaluate genetic and safety activity in a variety of animal models. Most manufacturers
have to propose to the FDA in advance what is called an Investigational New Drug (IND) request to
show outcomes of preclinical testing before it can be tried on humans. Typically studies in humans
are carried out in four parts, three of which must take place earlier to the FDA's approval period.
The first phase of the study is intended to set up safety, pharmacology, and safe drug dosage for
humans. ... Show more content on Helpwriting.net ...
The primary goal of Phase II of the study is comprised of patients with a specific disease and what
needs to be done to recognize the best dosage. The third phase of the process is set up to look at
effectiveness while reducing toxicity. These studies have generated an open data process on the
value and pigeonhole for most common short–term critical effects. Phase III is based on the huge,
essential experiments that are regularly used for the FDA authorization of a drug. This phase by and
large consist of a huge sample size (hundreds to thousands of patients) are use to estimate
... Get more on HelpWriting.net ...

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Types Of Rating Methods For Proposals That The Government...

  • 1. Types Of Rating Methods For Proposals That The Government... There are two types of rating methods for proposals that the government uses. One is the Numerical Method and the other is the Adjectival Method. Each method is based off each agencies preference. The numerical method is quite simple there are categories that can be used to rate such as total cost and or a combination of cost and non–cost on how the proposal meets the objectives that have been asking to fulfill. The rating scale is on bias way of being able to objectively provide no favoritism but use the facts. The scale adds up to 100. For an example it is like a grading rubric that is used on the grading of papers for universities. Each proposal will have a list of criterias or objectives that needs to be meant. Next you have a scale of percentages or a number scale that will give each one a weight to use in the rating part of each objective. Also, it 's common knowledge to list the most important task first on the proposal and that the vendors should be made aware on how the proposal will be weighted meaning if cost is more important or a combination of cost and non–cost. This allows the vendor equal opportunity to be able to tailor the proposal to give them a better chance in being picked and make the proposal reasonable so no one 's time is wasted. Last, rating method is adjectival which is a way of rating each proposal on a simple four to five categories. The scale could be a simple scale that consists of unacceptable, poor, satisfactory, good, and ... Get more on HelpWriting.net ...
  • 2.
  • 3. Company Structure And Its Types Grounded On Australian... Introduction: This report is based on the knowledge about company structure and its types grounded on Australian standards, the features which different organizations possess while functioning and the obligations implied on them in light of Australian standards. Secondly the major differences between large and small companies have also been discussed in this report, that what are those criteria which separate large companies from small? And the last part discusses the role which the organizations are playing in the progress of regulation of companies in Australia. The main purpose of these procedures is to bring uniformity in the regulatory system of Australian companies. Company Structure: A company's structure can be either private or ... Show more content on Helpwriting.net ... Hospitals, schools, old age houses, etc. are few of the examples of organizations which are limited by guarantee. (Makari, 2005) 3. No Liability Company: This type of company is only in Australia, specifically for the mining companies. It can be differentiated by any of the traditional companies their stakeholders are not responsible to pay calls on unpaid shares. Purchasing of their shares is supposed to bind the shareholders into a binding contract because of high degree of risk in the business of mining. 4. Unlimited Companies: Such type of companies formed with or without a shared capital, but the liabilities of the members are unlimited. At the time of company's liquidation for the payment of financial liabilities the members of the company are obligated to settle those liabilities. Proprietary (Private) Companies: Private companies don't have shares for general public. In case of selling their shares to a new shareholder requires approval from board of directors and with their mutual consent company's shares can be transferred to any new shareholder. Such companies are required to have at least one member up to the maximum limit of fifty members. These companies can be recognized as "Pty Ltd" in the last of their names. Private companies are further divided into two types: 1. Small Propriety Company: There are three conditions implied on these kinds of companies, i.e. Gross Revenue should be less than $25 Million, Gross Assets are less than $12.5 ... Get more on HelpWriting.net ...
  • 4.
  • 5. The Drug Development And Approval Process As mentioned in class, as well as in the required Krishna (2008) article, the drug development and approval process is an extensive and costly endeavor. The goal of experimental medicine is to increase the efficiency of drug development by providing a better understanding of the drug's mechanism(s) of action, dose response, efficacy, and safety, allowing the process to be accelerated for the most promising and efficacious candidates (Krishna, Herman, & Wagner, 2008). Preclinical testing begins with identifying the ideal drug target. The target should be disease–modifying and/or have a proven function in the pathophysiology of the disease. Target expression should not be uniformly distributed throughout the body. There should also be a favorable IP condition allowing the drug freedom to operate without competition. If the druggability is not obvious a 3D–structure for the target protein or a close homologue should be available for assessment. The target should also have favorable 'assayability' enabling high throughput screening. To identify these targets there are many strategies that can be utilized such as: genomic analysis (phenotype analysis, genetic association, gene expression profiling etc.), pathway analysis, and activity based proteomic profiling (Frank & Hargreaves, 2003; Lipsky & Sharp, 2001; Krishna, Herman, & Wagner, 2008). After conducting extensive animal studies in the laboratory and assessing the safety and biological activity of the drug compound, the ... Get more on HelpWriting.net ...
  • 6.
  • 7. Application For Approval Of Project RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCE BANGALORE KARNATAKA APPLICATION FOR APPROVAL OF PROJECT WORK PROJECT PROPOSAL 1 NAME OF THE CANDIDATE AND ADDRESS BINA SHRESTHA PADMASHREE SCHOOL OF PUBLIC HEALTH, NO 23, 80 FEET ROAD, GURUKRUPA LAYOUT, NAGARBHAVI, BANGALORE– 72 EMAILID: bina.shreshamph14@gmail.com 2 NAME OF THE NSTITUTIONPADMASHREE SCHOOL OF PUBLIC HEALTH 3COURSE OF STUDY AND SUBJECTMASTERS IN PUBLIC HEALTH4DATE OF ADMISSION TO COURSEOCTOBER 2014 5 TITLE OF THE TOPIC:– UTILIZATION OF MATERNAL HEALTH SERVICES IN A TARKESHWOR MUNICIPALITY, KATHAMANDU, NEPAL 6 BRIEF RESUME OF THE INTENDED WORK INTRODUCTION: Motherhood is a positive and fulfilling experience. But for some women it may be associated with suffering, ... Show more content on Helpwriting.net ... Health care delivery system may vary according to the country. In Nepal, Ministry of health and Population (MOHP) is the main body of health care delivery system. Under the MOHP, Department of Health Services (DoHS) delivers the entire health care service to the country. The Family Health Division, one of the divisions of Department of Health Services (DoHS) is responsible for delivering maternal health care services throughout the country. The division provides the maternal health services are through sub health posts (SHP) at each village development committee (VDC), health posts (HP) at each 5 VDCs, primary health care centers (PHC) at each of electoral constituency, district hospitals at each district, Zonal hospitals at each zone and Regional Hospital at each region. At community level, there is Village Health Workers (VHW), Female Community Health Volunteers (FCHV). For outreach areas, outreach clinics are conducted. SHP is the referral centre for TBAs and FCHVs as well as a venue for community–based activities such as PHC outreach clinics and EPI clinics. Maternal and child health workers (MCHW) provide antenatal and postnatal care and assist in–home deliveries whereas Auxiliary nurse midwives (ANM) provide antenatal and postnatal care as well as delivery at ... Get more on HelpWriting.net ...
  • 8.
  • 9. The Use Of Biologics And Medical Devices Should Be Strict The level of regulation governed by the FDA over drugs, biologics & medical devices is a widely debated topic. In my point of view, the level of regulation on drugs, biologics and medical devices should be strict. The current regulations governed by the FDA are very strict and should remain that way because the base of these regulations are underlined by various tragedies which we don't want to be repeated. For instance, the thalidomide incident in which many children were born with Phocomelia (shortening or absence of limbs). Thalidomide, which started as an OTC drug in 1957 as a remedy for sleeplessness was later found to have off–label effects such as mitigation of morning sickness in pregnant women. Hence was then prescribed worldwide to pregnant women. However, in 1962 Frances Kelsey prevented the approval of this drug in the USA. This resulted in Harris– Kefauver Amendment in 1962 which tightened the investigation and approval of drugs requiring the manufacturers to prove their safety and efficacy. Many incidents could be avoided in the past if the regulations were firm and so there is an utter necessity of governing bodies for oversight of clinical trials, new drug development and manufacturing of drugs, biologics and medical devices. Many of these unfortunate events were mishaps, but there are many such incidents which are the result of greed and corruption leading to adulteration of drugs, cosmetics and food products. Until the 19th century the slaughter, ... Get more on HelpWriting.net ...
  • 10.
  • 11. An Application For Ethical Approval At the initiation of the project, I signed a research agreement with the Athabasca Denesųłiné Né Né Land Corporation. The purpose of this agreement was to identify information sharing procedures. It includes depositing all primary research data in the oral traditions archive of the Athabasca Denesųłiné Né Né Land Corporation. This agreement facilitated the prior and informed consent to conduct research with Hatchet Lake, Black Lake and Fond du Lac Denesųłiné First Nations. This insures that the ownership of the project data remains with the Athabasca Denesųłiné. It also ensures that all knowledge holders remain anonymous in the dissertation. The research was conducted under the terms of an application for ethical approval for research ... Show more content on Helpwriting.net ... A numeral is associated with each knowledge holder. An additional numeral indicates Individual interviews. In this dissertation, AD0 identifies knowledge holders, and AD0–0 indicates individual interviews. Interview notes, recordings, and transcripts remain confidential. These are with the Athabasca Denesųłiné Né Né Land Corporation. Interviews were in English and Denesųłiné, assisted with the use of a translator. I vetted all interview data prior to inclusion in the dissertation. This ensures accuracy and maintains the confidentiality of sensitive information. The vetting process included opportunities for knowledge holders to expand on interview data. I also shared project results with communities during public community meetings and one–on–one with knowledge holders. I used plain language, as well as visual aids, including photos, maps and schematics. I used translation services when required. This dissertation sparing uses Denesųłiné terms. This approach better shares Denesųłiné understandings to an English audience. The text explains each Denesųłiné term as it appears in the dissertation. Materials reviewed included traditional land use studies. Up–to–date traditional land use information is in short supply, and much remains confidential. Denesųłiné traditional use information has been published by Athabasca Chipewyan First Nation (2003a:1–165, 2003b:1–97), Fort MacKay ... Get more on HelpWriting.net ...
  • 12.
  • 13. Eversource Seacoast Reliability Project Case Study The Ury et al. reading explains that a dispute resolution is used to diagnose an existing conflict, analyze how the stakeholders that are involved will interact and influence each other, and determine what processes are involved in resolving this conflict. The Eversource Seacoast Reliability Project (ESRP) requires approval from the Site Evaluation Committee (SEC), which means they must go through the SEC application and approval process. This SEC approval process in itself is a larger dispute system used to create an open relationship between the stakeholders as well as ensure that the developer meets all the requirements in the approval process. The ESRP can be dissected into a smaller dispute system within this SEC approval process with the main conflict of how to create a more reliable energy transmission line in the Seacoast area without drastically impacting the unique environment in the area. This is the main conflict that the proposed ... Show more content on Helpwriting.net ... I have found some information on the specific technology that will be used to bury the transmission line under the Great Bay, but I think it is important to understand what specific impacts this process will have and if there are alternative solutions to using this technology or technique. Many stakeholders are working on this issue including the Environmental Protection Agency (EPA), but they have not done an environmental assessment to address this issue. I think I will be able to find more information as I continue to research the project, but it would be beneficial to all the stakeholders for the engineering company to produce information pertaining to specific impacts that this project might cause or even hold a public meeting to further educate the other stakeholders on their technology and ... Get more on HelpWriting.net ...
  • 14.
  • 15. Evaluation Of The And Type Approval And Tests Task Name Part A – MMD_product_development 1.1 Electronics 1.1.1 PCB Design 1.2.Software 1.2.10 R2 Release tests 1.2.11 Error Corrections 1.2.12 R2 Interoperability tests 1.2.13 R2 Interoperability error correction 1.3. Mechanics 1.3.1 Industrial Design 1.3.3 PWB Outline modifications 1.3.5 Stack Tolerance Analysis 1.4. Verification 1.4.2 Test of Component 1.4.5 Validation tests of Product 1.4.6 File compilation of Technical Construction 1.4.7 Regulatory approval and type approval and tests 1.5. Build of prototype 1 1.5.1 Lead–time of P1 component 1.5.5 Build of P1 prototype 1.6. Build of prototype 2 1.6.5 Build of P2 prototype ... Show more content on Helpwriting.net ... Product From: Manager of the Project Date: December 8, 2014 Subject: Schedule of the Project will be improved Mr. Product, In the mail below I am connecting the agenda of the project in email for the orientation and I connect the augmentation of the project. Systematically once computation was finished it was commence that the conclusion project date is 17/08/2015. On the whole project duration is 233 days. So, beneath are the features which will origin the long length of the project which will be linked with task which are dangerous with the project like developments of the Database and the UI and then the test plan and Project design Review. All tasks which will be organized and not compulsory to evade any of tasks leave out without the previous one will be completed and begin the other one, maintaining the dependence of the ... Get more on HelpWriting.net ...
  • 16.
  • 17. The Drug Development And Approval Process As mentioned in class, as well as in the Krishna (2008) article, the drug development and approval process is an extensive and costly endeavor. The goal of experimental medicine is to increase the efficiency of drug development by providing a better understanding of the drug's mechanism(s) of action, dose response, efficacy, and safety, allowing the process to be accelerated for the most promising and efficacious candidates (Krishna, Herman, & Wagner, 2008). Preclinical testing begins with identifying the ideal drug target. The target should be disease–modifying and/or have a proven function in the pathophysiology of the disease. Target expression should not be uniformly distributed throughout the body. There should also be a favorable IP ... Show more content on Helpwriting.net ... The main goal in Phase I is to find out if the investigational new drug is safe. In this first phase of human testing, testing determines the correct dosing and exposes the most common side effects. If the investigational new drug is found to be safe, Phase II of human testing can begin. The main goal of Phase II is to find out if the investigational new drug is effective. Unlike in Phase I, the patients tested in Phase II are not healthy. In this phase, testing determines whether the drug works on patients it was designed to help. Results are obtained by comparing the group of test patients to other groups taking a different drug or taking a placebo. Phase III is the first large–scale trial of human testing. This phase can only begin if the new drug shows to be effective in Phase II. Phase III seeks to further determine the effectiveness of the drug. This is done by testing the drug on different populations, meaning that testing will be done on more people, testing will be done with different drug doses, and the drug will be tested on patients who are also taking other drugs. If Phases I through III show the investigational new drug to be safe and effective, then the pharmaceutical company will file a New Drug Application (NDA). The NDA includes both the results of the first three trial phases and data on how the drug is manufactured (Frank & Hargreaves, 2003; Lipsky & Sharp, 2001; Krishna, ... Get more on HelpWriting.net ...
  • 18.
  • 19. Summary: Sharepoint Approval Iteration 5 SharePoint Approval The last iteration is the approval of the implemented SharePoint administration technology. The approval iteration level helps to ascertain the organization needs for the purpose of meeting project requirements. Before the approval of the SharePoint administrator technology, experts will test the system to verify if it meets the project needs (Solomon, 2011). Plan Having developed and installed the new system to the organization, I plan to approve and check on whether the system operates effectively. I plan to ensure that all configurations, testing, and checking issues are factors. The move will focus on the selection of the ideal operations within the company (Arnold, 2012). The experts will work with me during system configuration so as to ensure that the new SharePoint administrator technology and proposed backup system integrate with accordance. I plan to check on all components of the system and ensure that they are fixed in accordance. ... Show more content on Helpwriting.net ... Such a move was attributed to the fact that, they wanted to prove that the proposed system helps the company operate more effectively. Senior administrator was more on ensuring that the system installed was not default in nature. The customization process of the ideal system was put in a greater focus and that enabled the company gets appropriate information technology system (Diffin, 2010). The company had a suitable information technology system with qualified personnel and its machines were in the right condition. I observed that the company had an IT expert who oversaw all the operations carried out by selected team. Use of high–quality equipment within the operations platform made the management buy the idea of installing the SharePoint administrator technology system plus the data backup system. The company had all its trust on my advice, training, and design of the new system (Carr, ... Get more on HelpWriting.net ...
  • 20.
  • 21. The Latino Political Experience : The Electoral Based And... Question 3 The Latino political experience, much like the experience of other minority groups, has been about fighting for inclusion. In order to be included into mainstream society Latinos had to use different methods to get their grievances heard. In a system that was not designed to benefit minorities, Latinos had to put aside their differences and come together in order to address to economic, political, and social marginalization they faced. Due to restructuring and globalization large segments of the Latino population were excluded from effective economic and political access and participation. As their numbers increased Latinos began to utilize different methods to address the changes in their communities. They used two main methods which reflected two conceptions of empowerment, the electoral based and the household model. The electoral based model is a form of empowerment that focuses on mainstream electoral politics. It is based on the assumption that the traditional electoral system is capable of addressing latino issues and having a policy agenda reflects the interests of latinos. This model use the political system and the use of institutional power to gain inclusion and recognition in the politics. It is focused on getting greater number of Latinos in office in order to have representatives who are actually Latino. The goal however, is to gain inclusion into the existing system instead of reforming it because it fails to give all people equal access. The ... Get more on HelpWriting.net ...
  • 22.
  • 23. Arguments Against Approval Voting In the United States, we currently use a system of voting called Plurality voting. Under this system, each voter is allowed to cast one vote for their preferred candidate. Approval Voting is a system of voting where are authorized to vote for as many candidates as they "approve" of instead of a single candidate. As in plurality voting, the most "approved of" candidate wins the election. It is unlikely that the US will shift from a plurality voting system to an approval voting system because the approval voting system turns discretionary power from party leaders to the people. Before the primaries, a presidential candidate was chosen by party leaders. These leaders include important officeholders and party officials, such as activists who ... Show more content on Helpwriting.net ... Those with special interests are more concerned about their special interests than the "right" of the American people. Without campaign finance reform, politicians are beholden to the special interests, and party leaders along with their special interest groups will continue to want to control elections. Nonetheless, it is interesting to contemplate how a different voting system might influence elections and politics if the current regime were changed. In 1977 Guy Ottewell popularized a voting system called "Approval Voting. Under Approval Voting, voters are allowed to vote for all the candidates that they approved. By voting for all of the candidates they like, voters do not have to decide who they like best; they can choose all of the candidates with platforms that are of interest to the voter. This system mainly favors candidates who voters believe "probably can't win" so they vote for candidates who they believe "can win" even if they don't like them the best. Approval Voting allows these supporters to vote for both candidates; they will not be tempted to desert the one who is weak in the polls as under plurality voting. So, minority candidates tend to receive votes which reflect their actual level of ... Get more on HelpWriting.net ...
  • 24.
  • 25. Development Of Generic Product And Approval Generally, an ANDA sponsor of the topical dermatological product has to undergo multiple review cycles with the FDA before the product gets approved and the sponsor has to wait for a longer time mostly. Even though the ICH CTD, ICH Q8 describes the generation of product development report, it is not still clear to ANDA sponsors how this actually applies. As a result, more internal meetings and discussions between the sponsors and the FDA delays the product approval. One of the ways to overcome these challenges is to have a product development report with verified and justified specifications based on the QbD efforts which can help the Office of Generic Drugs (OGD) to be efficient in understanding the developed generic product and approval ... Show more content on Helpwriting.net ... The foremost criteria in developing a generic topical dermatological product is to meet the pharmaceutical and therapeutic equivalency of the RLD. A therapeutic equivalence is the one which has the same clinical effect and safety profile as given in the label of the RLD and a pharmaceutical equivalence is the one which contains identical amount of same active ingredient corresponding to the same route of administration in the same dosage form with similar mechanism of release and similar rate and extent of the absorption of the RLD. The current paradigm to get an approval by an ANDA sponsor is by proving the therapeutic equivalence to the RLD by testing whereas the proposed QbD approach requires the sponsors to meet the equivalence on the basis of defined design targets. More specifically, a well–defined rational approach behind each testing is required for proving the pharmaceutical equivalence and bioequivalence [18]. When talking about the design of equivalence of a generic dermatological topical product, the criteria for Q1 and Q2. Additionally, in some cases, the Q3 criteria has to be satisfied in addition to Q1 and Q2 Topical solutions can be stated as an example for Q3. The Q1, Q2 and Q3 may not be a feasible option if the patent of the RLD is considerably protected. In such cases, the generic manufacturer may be in a position to look for alternate ... Get more on HelpWriting.net ...
  • 26.
  • 27. Fda Approval Process Of Drugs Essay Joston Toney Nicole Thompson English 2010 Online 03 December 2016 The FDAApproval Process of Drugs When I was a kid, I always wondered why it took so long for an ill person to become well again. I always thought that if the ill person went to the doctor they would be back to normal the next day, but that's not the case. For some people it took several days, weeks, months, and even years to conquer an illness but as a child I never could understand that. I don't know how many times I've asked my mom or dad how come the doctors don't get together and make a "miracle" drug that could heal anything and everything. It wasn't until the age of 15 when my grandmother was diagnosed with breast cancer that I understood why it took so long for others to heal and the process that they had to endure in order to be healthy again. Shortly after my grandmother's diagnosis, I started looking into what it would take to get a drug that would cure cancer through the approval process on the shelf to save some many others just like my grandmother. But I kept running into a dead end. Everything seemed to keep pointing towards chemotherapy and radiation. Although I wanted something to heal my grandmother fast, chemotherapy and radiation was the only solution if I had wish to see her watch me graduate high school. I went to almost every appointment with her to watch how it helped strengthen but also watch as it drained her energy. A month of chemotherapy and a few weeks of radiation and my ... Get more on HelpWriting.net ...
  • 28.
  • 29. Presidential Approval Ratings The War on Terrorism and Presidential Approval Ratings With war, there are politics. With politics, there may be war. The perspective of man has a monumental impact even on the most minuet things to greater issues that affect society as a whole. Within the realm of politics, specifically the United States, there is democracy in which constituents choose their representatives. There is a general understanding that these representatives are elected to provide the best representation and voice of the people; however, the public's opinion and the responsibility of utilitarianism of the country that the President must consider can sometimes collide. The rise of Osama Bin Laden and formation of the terrorist group, al Qaeda, with its terroristic ... Show more content on Helpwriting.net ... According to data gathered by Hetherington and Nelson using Gallup Polls, President Bush's job approval rating was 51% the day before the terrorist attack and dramatically increased to 90% by September 22, which was "the highest rating ever recorded for a president" (2003, 36: 37). Comparing Gallup Polls taken a month before the September 11 attacks and September 22 reveals how the rally 'round the flag effect impacted presidential approval from the different political parties of the United States(Hetherington and Nelson 2003, 36: 39). Hetherington and Nelson's research shows the changes of presidential job approval rose from 89% to 98% among Republicans, Independents increasing from 53% to 91%, and approval among Democrats jumped from a dismal 28% to 84% (2003, 36: 39). President Bush used this surge in approval ratings to help his fellow Republicans win seats in the November 2002 midterm elections, ultimately taking control of both the House of Representatives and Senate (Hetherington and Nelson 2003, 36: 42). On September 14, 2001 President Bush visited ground zero and addressed rescue workers with a bullhorn in a passionate and unscripted speech that resonated with Americans. Several members of the audience shouted that they could not hear President Bush. The President responded with "I can hear you. The rest of the world hears you. And the people who knocked down these buildings will hear all of us soon" (Gregg 2003, 32: 145). Soon thereafter President Bush received near unanimous support from both houses of Congress when they passed a joint resolution giving the president permission to use "all necessary and ... Get more on HelpWriting.net ...
  • 30.
  • 31. [unused38]on's Moral Sense, By Hutcheson And Shaftesbury Hutcheson and Shaftesbury believed that human nature contained all it needed to make moral decisions, along with inclinations to be moral. Moral sense is a kind of sense because, like external senses, it is common to all mankind. It is independent of our will and its deliverances are not conclusions mediated by premises. In particular it is not mediated by considerations of personal advantage or harm. It is on account of this feature that we are able to admire actions that took place in remote times and regions and even actions that are contrary to our own interests . Moral philosophers say that the main contribution of Hutcheson to the concept of moral sense is that he describes the working of moral sense. The process, Hutcheson described, ... Show more content on Helpwriting.net ... Approbation of our own action is given when we are pleased with ourselves for doing the action and/or pleased with our intentions for doing the action. Hutcheson puts it this way: "Approbation of our own action denotes, or is attended with, a pleasure in the contemplation of it, and in reflection upon the affections which inclined us to it" . Consider what happens when someone picks up and returns something that another person drops. In response to the action, the person who picked up the dropped item would have feelings of approbation toward his own action. This person would be happy with what he did, especially after giving it some thought. Further, they would be pleased if their own intentions were ones with which they could also be pleased. The intention could possibly be that they just wanted to help this person; however, if the intention was to gain advantage with the other person, then they would not be as pleased with themselves. Approbation of another's action is much the same except that the observer is pleased to witness the action of the other person and feels affection toward the agent of the action. Again Hutcheson writes: "Approbation of the action of another has some little pleasure in attending it in the observer, and raises love toward the agent, in whom the quality approved is deemed to reside, and not in the observer, who has ... Get more on HelpWriting.net ...
  • 32.
  • 33. The Drug Development And Approval Process As mentioned in class, as well as in the Krishna (2008) article, the drug development and approval process is an extensive and costly endeavor. The goal of experimental medicine is to increase the efficiency of drug development by providing a better understanding of the drug's mechanism(s) of action, dose response, efficacy, and safety, allowing the process to be accelerated for the most promising and efficacious candidates (Krishna, Herman, & Wagner, 2008). Preclinical testing begins with identifying the ideal drug target. The target should be disease–modifying and/or have a proven function in the pathophysiology of the disease. Target expression should not be uniformly distributed throughout the body. There should also be a favorable IP condition allowing the drug freedom to operate without competition. If the druggability is not obvious, a 3D–structure for the target protein or a close homologue should be available for assessment. The target should also have favorable 'assayability' enabling high throughput screening. To identify these targets there are many strategies that can be utilized such as: genomic analysis (phenotype analysis, genetic association, gene expression profiling, etc.), pathway analysis, and activity–based proteomic profiling (Frank & Hargreaves, 2003; Lipsky & Sharp, 2001; Krishna, Herman, & Wagner, 2008). After conducting extensive animal studies in the laboratory and assessing the safety and biological activity of the drug compound, the ... Get more on HelpWriting.net ...
  • 34.
  • 35. Marketing Approval For Medicinal Products Essay There are accelerated pathways in different countries to make available new therapy for their patients, who have unmet needs. The USA, UK and Japan are offering an accelerated marketing approval for the medicinal products. USA: USFDA is offering a Fast Track, Breakthrough Therapy, Accelerated Approval, and Priority Review options to expedite the medicinal products approval. Fast Track designation – drugs that treat serious illnesses and fulfill unmet medical needs, manufacturer gets more support and advice from the FDA to accelerate the approval process. Breakthrough Therapy – medicinal product that supports unmet need and shows important benefits over existing drugs gets fast track designation, and gets more intensive guidance from the FDA. Accelerated Approval process –drugs that fulfill an unmet need in a serious condition, and that can establish an effect on a substitute indicator or intermediary clinical endpoint can get early approval before providing full clinical data, but company has to make a commitment to conduct phase IV confirmatory trials (FDA, 2016). Priority Review –Approval process time reduced from 10 months to 6 months. UK: In the UK, the early access medicine scheme introduced in the year 2014 for the purpose of allowing patients who suffer from life threatening or serious worsening medical conditions to access the medicines that did not get yet a marketing authorization. An application of Promising Innovative Medicines (PIM) to the MHRA (Medicines ... Get more on HelpWriting.net ...
  • 36.
  • 37. The Quality Of A Person 's Relationships With Their... This research is designed to answer the following question: Does the quality of a person's relationships with their parents and with their peers influence the extent to which that person engages in marijuana use? "Data for this study come from the [seventh wave of the] National Youth Survey (NYS). The NYS is a nationally representative, longitudinal survey of 1,725 U.S. youth between the ages of 11 and 17 at the time of the first interview in early 1977. Respondents were interviewed annually through 1981 (Waves 1–5) and then again in 1984 (Wave 6) and 1987 (Wave 7). By the last wave of interviews, respondents were between the ages of 21 and 27 years" (King & South, 2011, p. 107). The variables used consisted of two independent variables, Perceived Disapproval by Parents Towards Deviance and Perceived Disapproval by Peers Towards Deviance, and the dependent variable of Marijuana Use. The variable Perceived Disapproval by Parents was operationalized by creating a composite variable from the following questions: "PARENTS OPIN: CHEAT ON INCOME TAX (Y7_378), PARENTS OPIN: STOLEN WORTH <$5 (Y7_379), PARENTS OPIN: SOLD HARD DRUGS (Y7_380), PARENTS OPIN: USED MARIJUANA (Y7_381), PARENTS OPIN: STOLE WORTH >$50 (Y7_382), PARENTS OPIN: HIT SOMEONE (Y7_383), PARENTS OPIN: DESTROYED PROPERTY (Y7_385), PARENTS OPIN: BROKE INTO VEHICLE (Y7_386), PARENTS OPIN: DELIB HURT SP/PARTN (Y7_387)" (National Youth Survey [United States]: Wave VII, 1987). The composite variable was created by taking ... Get more on HelpWriting.net ...
  • 38.
  • 39. The Drug Approval Of The Disease Essay There are over 7,000 rare diseases affecting between 25 and 30 million Americans (Global Genes 2016). A disease or disorder is defined as rare in the U.S when it affects fewer than 200,000 Americans at any given time (Eurordis 2016). Some of these rare diseases come with even more rare and controversial decisions. "The FDA just made its most controversial drug approval of the year" (Fortune 2016). This injectable drug is called eteplirsen by Sarepta Therapeutics and it is an exon– skipping drug targeting a section of genetic code called "exon 51" in the dystrophin gene. Exon skipping is a type of strategy that is being developed for the rare disease DMD (Duchenne Muscular Dystrophy). The exon–skipping process skips sections of genetic codes during protein manufacturing, allowing cells to create shortened but partially functional dystrophin protein which is the muscle protein that is missing in DMD. This rare X–linked disease was first described in the 1850's by French neurologists Guillaume Duchenne but was not known to inhibit the production of protein dystrophin and result in the loss of motor functions and muscular degeneration until the 1980's (MDA 2016). 1 in 3600–6000 live male births has resulted in DMD (Bushby 2010). Most patients are diagnosed around 5 years of age when their physical abilities are no longer similar to their peers (Bushby 2010). If left untreated, signs of deterioration in muscle strength increase, the chance of using a wheelchair before their teens ... Get more on HelpWriting.net ...
  • 40.
  • 41. Corporate Law And Shareholder Approval Most equity carve–outs do not require shareholder approval and require only approval by the parent company's and subsidiary company's boards of directors. More complicated corporate law considerations, particularly those related to fiduciary duties, typically arise following the closing of an equity carve–out, especially if the parent retains a significant equity interest in the subsidiary. Shareholder Approval The question of whether shareholder approval is required to implement an equity carve–out is determined by state law. While shareholder approval statutes vary by state, most are substantially similar to Delaware's statute, which provides that shareholders must approve a transaction in which a company will sell all or substantially ... Show more content on Helpwriting.net ... Most equity carve–outs are not large enough to require shareholder approval; if the parent sells less than a majority stake and retains control over the subsidiary, there is a strong argument against needing to obtain shareholder approval. If the parent sells between 50% and 100% of its subsidiary shares, on the other hand, and the subsidiary's business is important to the parent, there is a strong argument in support of needing shareholder approval. The requirement for shareholder approval is significant because proxy materials must be mailed, a shareholder meeting must be organized and approval must be obtained before the transaction can be completed. If the parent's shares are registered under the Exchange Act, proxy materials must comply with Regulation 14A and meet disclosure requirements. While proxy materials should disclose the material terms of the offering, details such as final price and size of the offering are typically not determined until the registration statement is effective, which creates a risk that the parent will not be able to meet its disclosure obligations. Board Approval Approval is typically required by both the parent's and the subsidiary's boards of directors in order to implement an equity carve–out. While the specific ... Get more on HelpWriting.net ...
  • 42.
  • 43. Quality And Safe Product Approval System 1. Objective To undertake a critical review of the current product check and release processes to ensure a robust, high quality and safe product approval system is in place to safeguard patient safety and to ensure compliance with standards and recommendations. 2. Background The aseptic preparation of products at Northern Lincolnshire and Goole NHS Foundation Trust (NLAG) is carried out in an unlicensed unit under Section 10 exemption of the Medicines Act 1968. (1) It requires that the preparation is done by or under the supervision of a Pharmacist, who takes full responsibility for the quality of the product. Until recently, in unlicensed units working under Section 10 exemption, even if the final checks were carried out by ... Show more content on Helpwriting.net ... It provides a proposed product approval/Pharmacist supervision model that has been attached in Appendix 1. Final product accuracy check and release at NLAG is undertaken by the Authorised Pharmacist (usually band 7 or above). The Authorised Pharmacist also undertakes the clinical checks/screening of the prescriptions. It has been discussed that undertaking these checks by different pharmacists will add an extra safety check in the process and there is a plan for separation of these roles in the near future. The plan is to have a Clinical Pharmacist undertaking the clinical checks in the clinical area and an Authorised Pharmacist in the Aseptic Unit undertaking the product check and approval (release). Another proposal has been suggested following this analysis. There are some concerns regarding separation of the roles as the staff who may be involved in approving products (band 6 pharmacists) have a lack of knowledge and skills in aseptics. There is also a need for cost effective working and flexibility within the service, including appropriate skill– mix. This all emphasises a requirement for this critical analysis to ensure that a robust product check and release is undertaken. Although errors in the preparation of injectable medicines within pharmacy aseptic environments are not very ... Get more on HelpWriting.net ...
  • 44.
  • 45. Tattoos : Self Expression Or Approval? Tattoos: Self Expression or Approval? Ink that is normally used on paper is submerged into layers of my skin. While staring at the permanent feature, I wonder was this a way of me expressing myself using my body, or the approval of myself and others? At the age of fourteen, preteen girls are normally focused on buying the latest purses or shoes, but that was not the case for me. Throughout my first year of high school my mind was solely set on getting a tattoo. Being so young, my mother was very hesitant to allow me to permanently ink my skin. However, when I was ten, I went against my mother's word by getting my second hole on my ears pierced even after she advised against it. Knowing my determination in getting the things I want, she made a deal with me. The deal being that I had to take a full year to consider the tattoo and if I was still fixed on it she would allow me. As the year passed, I had only one idea in mind that never changed. I wanted the tattoo to be meaningful and something I would not regret. The idea of this being permanent, unchangeable, and forever on my skin for the rest of my life was fearful. Growing up my mother had sayings for my brother and I that was written in every text and inscribed in every card. "Stay Sweet", two words that have been engraved in my head since before I could speak. It was clear, without hesitation, that I was ready to have these words also engraved in my skin. Almost four years later and I wonder what did this small form of ... Get more on HelpWriting.net ...
  • 46.
  • 47. The Drug Development And Approval Process As mentioned in class, as well as in the required Krishna (2008) article, the drug development and approval process is an extensive and costly endeavor. The goal of experimental medicine is to increase the efficiency of drug development by providing a better understanding of the drug's mechanism(s) of action, dose response, efficacy, and safety, allowing the process to be accelerated for the most promising and efficacious candidates (Krishna, Herman, & Wagner, 2008). Preclinical testing begins with identifying the ideal drug target. The target should be disease–modifying and/or have a proven function in the pathophysiology of the disease. Target expression should not be uniformly distributed throughout the body. There should also be a ... Show more content on Helpwriting.net ... The main goal in Phase I is to find out if the investigational new drug is safe. In this first phase of human testing, testing determines the correct dosing and exposes the most common side effects. If the investigational new drug is found to be safe, Phase II of human testing can begin. The main goal of Phase II is to find out if the investigational new drug is effective. Unlike in Phase I, the patients tested in Phase II are not healthy. In this phase, testing determines whether the drug works on patients it was designed to help. Results are obtained by comparing the group of test patients to other groups taking a different drug or taking a placebo. Phase III is the first large–scale trial of human testing. This phase can only begin if the new drug shows to be effective in the phase II. Phase III seeks to further determine the effectiveness of the drug. This is done by testing the drug on different populations, meaning that testing will be done on more people, testing will be done on different drug doses, and the drug will be tested on patients who are also taking other drugs. If Phases I through III show the investigational new drug to be safe and effective, then the pharmaceutical company will file a New Drug Application (NDA). The NDA includes both the results of the first three trial phases and data on how the drug is manufactured (Frank & Hargreaves, 2003; Lipsky & Sharp, 2001; ... Get more on HelpWriting.net ...
  • 48.
  • 49. Approval Of The Institutional Review Board Prior to the conduction of this study, the researcher sought the approval of the Institutional Review Board with the Protection of Human Subjects in research. The researcher completed re–certification with the Institutional Review Board training on May 29, 2014 (See Appendix C). The researcher provided IRB with information such as research protocol, interview protocol, Demographic Questionnaire, researcher's background information, consent form, and investigator's assurance. Upon IRB approval, the research contacted the contacted the Superintendent of each school district for their permission to conduct the study in their districts. Next the principals of the schools were contacted for their permission to interview teachers in their building. At this point, the research was able to contact the participants for an interview. The Principals, after permission was given for the study, were asked to provide the participants e–mail addresses and phone numbers. In this qualitative phenomenological research, the researcher went to the building that the participants' schools were located for participants' convenience. The researcher followed a protocol of first conducting individual interviews with each of the ten participants. A semi–structured, conversational style of individual interviewing was adopted in order to explore the respondents' stories which made interviewing multiple subjects more methodical (See Appendix A for Interview Protocol). According to Meehan, 20014), ... Get more on HelpWriting.net ...
  • 50.
  • 51. Common American Pizza Essay In 1905 the United States of America hit an incredible milestone. The first pizzeria was opened in Manhattan, called Lombardi's. Since that glorious day American's have enjoyed the delicious taste of pizza. Pizza is a world–wide food that is savored in many countries across the globe. It was first created in Naples, as an inexpensive food for un–wealthy common folks. It started out as flatbreads topped with assorted fixings like cheese, oil, tomatoes, and garlic. Pizza has evolved over time into what we know it as today. Popular toppings on the common American pizza are sausage, pepperoni, cheese, veggie, and bacon. It would be interesting to see which of the five options would be the most popular and which option would be the least popular. ... Show more content on Helpwriting.net ... This method is carried out in different rounds, where one pizza topping will be dropped after each round. The pizza topping that has the fewest first place votes gets eliminated. When there are only two pizza toppings remaining the topping with the most first place votes is the winner of plurality with elimination. I created a table to show the results of the different rounds. The table is similar to the preference chart, but the rows are only showing the first place selections. It is important to understand that whenever a pizza topping gets eliminated it is taken out of the order. The pizza topping that was directly below the one that got eliminated will move up in the order. For example, the first round bacon got the least amount of first place votes. Therefore, bacon was eliminated and anything below bacon was moved up in ranking. So if the order was bacon, sausage, pepperoni, cheese, then veggie the order would change to sausage, pepperoni, cheese, then veggie to accommodate the fact that bacon was eliminated. Looking at the second round on the chart, the orders changed significantly as well as the scores. In the second round, veggie got eliminated leaving pepperoni, sausage, and cheese still in the running. In the third and final round pepperoni was eliminated. The pizza topping that had the most first place votes after eliminating pepperoni was ... Get more on HelpWriting.net ...
  • 52.
  • 53. Ethical Approval Form For Undergraduate Projects DIVISION OF PSYCHOLOGY & COUNSELLING, UNIVERSITY OF HUDDERSFIELD ETHICAL APPROVAL FORM FOR UNDERGRADUATE PROJECTS Part One Project Title Hot or not ? Assessing changing social attitudes to body image and attractiveness through a study of TV advertising Student name Pandora Papamichael Supervisor name Christopher Bale Date Yes No N/A 1 Will you describe to participants what will happen in your study (e.g. experimental or interview procedures) in advance, so that they are informed about what to expect? 2 Will you tell participants that their participation is voluntary? 3 Will you obtain written consent for participation? 4 If the research is observational, will you ask participants for their consent to being observed? ... Show more content on Helpwriting.net ... YES NO N/A 9 Will your project involve deliberately misleading participants in any way? 10 Is there any realistic risk of any participants experiencing either physical or psychological distress or discomfort? If Yes, give details in part three of this form, and state what you will tell them to do if they should experience any problems (e.g. who they can contact for help). 11 Does your project involve work with animals? . 12 Do participants fall into any of the following special groups? If they do, please refer to the guidance notes and provide the justification required in part three Prisoners, children (under 18), NHS patients, NHS staff, Social Services clients and other vulnerable adults. 13 Are there any threats to your safety (either physical or psychological) in carrying out this research? If you have ticked Yes to any of Q9–12, please make sure you give an explanation on Part Three of the form. You do not have to complete Part three I fyou have answered NO to all questions.
  • 54. There is an obligation on the student to bring to the attention of the module leader any issues with ethical implications not clearly covered by the above checklist. Part Two In this section you need to provide more details about your project. Please complete the table below. Project title Hot or not ? Assessing social attitudes to body image and attractiveness through a study of TV advertising Project aims/ hypotheses To see how people feel about ... Get more on HelpWriting.net ...
  • 55.
  • 56. Project Rfp And Bids Approval 1. CR Status Project RFP/Bids CR Status Mezzanine Bids Received Approved Pump House Bids Received Approved Snow Melter Approved Micro Turbine Approved SMG Pump and Boiler Skids Bids Received Approved SMG Mechanical / Electrical Approved SMG Plumbing CRs in process Big House Columns Bid Received Approved Summit BOS Facility Approved 2. Waste Heat and Fuel Piping Discussion – CPS met with NSF, ALEX and CRREL on Jan 27th to discuss the proposed plan. Notes and a site plan for the buried lines at Summit are attached for review (Attachment A). B. Raven 1. Raven Camp CR – CPS is waiting for direction from NSF to submit this CR. Has there been any discussions with AIL? Should this CR be submitted? 2. Raven Power System Options – CPS has ... Show more content on Helpwriting.net ... Action Items: 1. CPS (Sever) to check with IAB if any permits are required from BLM for the USDA Labs to be installed at Toolik. The permit is based on the Toolik LRFP, which will be updated for IAB to provide to BLM. CPS has started the process of updating the LRFP document. Ongoing 2. CPS (Smith) to develop an estimate of the long term maintenance costs of the BEO power line. UIC is working with AK Line Builders to obtain pricing. Ongoing 3. CPS (Raine/Burnside) to develop a list of assets required for the GrIT and SCAT to help define "what is" GrIT and SCAT. Ongoing 4. CPS (Sever) to develop a final report of the SMG Fabrication, including costs and weights. This will be used to assess similar structures in the future and to share with AIL. Include info on the pull test performed by CRREL. Ongoing 5. CPS (Timmons) to develop an estimate for a new Summit Utilidor. NSF has proposed changing the concept for Summit to elevated structure eliminating the need for the Utilidor. This actions item is overcome by events, recommending closing. Complete 6. CPS (Jay/Jessy) to develop an analysis of vehicle usage for Thule and provide a recommendation
  • 57. on lease vs own. CPS has revised the paper and a final version will be provided for review. Ongoing 7. CPS (Burnside/Wahl) to assess all equipment to determine if there are outstanding recalls and develop a process to do this annually. Jeff has started this process. Ongoing 8. CPS ... Get more on HelpWriting.net ...
  • 58.
  • 59. FDA's Approval of Prescription Drugs Essay There are many direct to consumer advertising for prescription drugs. On television, magazines, radio etc, you see the most recent advertisements for prescription drugs. After some people see the advertisements they soon rush over to their doctor and their illness and life would be perfectly pain and stress free. Making the public conscious of options for treatment is not a bad thing. But these false advertisements are misleading consumers onto unnecessary treatment. Advertisements have one primary purpose that is to persuade. Prescription medications Ads tell the consumers to get treatment and also imply that they have the need for it to solve their problems. Since prescription Ads have been introduced, the pharmaceutical ... Show more content on Helpwriting.net ... Merck will soon face many challenges in the business of producing drugs. The company's most popular drugs are coming to a close to their patent expiration. One of the best selling drugs is called Zocar, which is used for cholesterol problems. Zocar will have to soon face competition next June from other generic drug makers. The elimination of Zocar from the market will erase the $5.2 billion sales annually. Fosomax, an osteoporosis relieving drug, produced by Merck will soon lose the$ 2.2 billion annual sales because of the expiration of its patent. Also, another problem is the struggles recently to find new medicines. The prescription painkiller drug, which was introduced in 1999, is called Vioxx. Vioxx was introduced by Merck and co. Vioxx served the purpose of being a painkiller in the relief of osteoarthritis, rheumatoid arthritis, painful menstruation and other types of acute pain. This painkilling drug would be classified as a non–inflammatory drug (NSAIDs). Last year, in September 2004, Merck withdrawed Vioxx, off the market. Studies of Vioxx showed that it doubled the risk of a heart attack or stroke for patients who have used it more than 18 months. After Merck, withdrawed Vioxx from the market, the FDA, issued a public health advisory for the users of Vioxx. Therefore, Vioxx was on the market for five years without ... Get more on HelpWriting.net ...
  • 60.
  • 61. Importance Of Approval In Nursing Topic approval Summary: in the unit where I work there are approximately 8 to 12 doctors, and 2 nurse practitioners writing orders on any given day. Each of these providers have their own template that they use to chart in the patient's chart that automatically populates most of the information to fill out things like there H&P. An interesting issue is that of all these providers none of their templates are the same. They have shared with one another, and then customized to suit their individual preferences. But none of them have a template that addresses all the requirements needed to justify and/or support any orders that they may submit to be processed. This causes the patient to have the expectation that whatever the physician has promised ... Show more content on Helpwriting.net ... This ultimately ends up with the patient not receiving what the doctor had promised on the 1st visit to have ordered. The patient never blames their insurance company but blames the facility that I work for. My approval plan is to simply have an insert to put into all the physicians templates a small clause that would require the physicians to address all the reasons that any order would be denied. This will save at least 4 personnel from attempting getting approval for orders that they know have not met the insurance requirements. To do this it will take a lot of collaboration with all the providers to be willing to take a few extra steps, or to at that point tell the patient that you must do this (physical therapy) for example before your insurance company will prove the order that I suggest. This will either require the patient to fully comply with the requirements or prerequisites of their insurance company, and if they choose not to, then it can be explained that this order will not be approved and we will not submit it until all the requirements are fulfilled. This will save many man–hours that we are currently devoting this task knowing that it will fail. As well as not setting the patient's expectations for something that we know will ... Get more on HelpWriting.net ...
  • 62.
  • 63. The Drug Approval Process Essay The drug approval process is a complicated labyrinth that sometimes seems impossible to navigate. There are guidelines, protocols, procedures and standards that each person in the process are expected to follow. This includes the doctors, principle investigators, researchers, pharmaceutical companies, the regulatory bodies and yes, the patients. The patients are by far the most important aspect of a clinical trial and obtaining drug approval. Without the willing volunteers in clinical trials there would not be treatments and cures for many diseases today. There are a lot of factors that go into getting a new medication to the open market, including many phases of clinical research. The roles of the FDA, various research laboratories and the pharmaceutical companies all play a pivotal role in the time that it takes to obtain drug approval. There are many obstacles associated with each step including funding and how that impacts the consumer costs. Our country began with no limitations on goods and quickly progressed to enforcing accurate labeling and mandatory testing. This has advanced to enforcing challenging scientific standards, which tend to be somewhat controversial today. The years between 1938 and 1951 are pegged "The birth of the modern pharmaceutical trade: the Revolution in medicine" according to Philip Hilts (2003). The industry went from just a few chemical companies to an explosive initiative to discover, develop and market drugs at a rapid pace. This was ... Get more on HelpWriting.net ...
  • 64.
  • 65. Increasing the Approval Ratings for President Obama "What Should I do To Increase My Approval Rating?" Introduction When my iPhone said "The White House" I thought it was the local restaurant I had made reservations over the weekend for my parent's anniversary. There was a very stern voice that said "President Obama needs your opinion on the current approval ratings, please hold for the President of the United States of America"¦and we thank you for your service"¦" Wow! President Obama wanted advice on how to improve his approval rating. I laid out my three point plan I have long been advocating throughout the debates (I have had with my family and friends). Three Point Plan to Increase Approval Ratings The most critical area of President Obama's approval rating has to do with the economy. To get America back to work as quickly as possible I proposed he immediately create new venture economic opportunity zones throughout the U.S., concentrating on those areas hardest hit by the recession. I'd focus specifically on Ohio, which has lost hundreds of thousands of jobs. My plan would be to roll out entrepreneurial assistance to new ventures with a solid business plan, and also a strong management team. Creating and fostering entrepreneurialism is critical for the overall successful functioning of a complex economy such as the U.S. (Trimi, Berbegal–Mirabent, 463). I would tell him that he also needs to become known as the Entrepreneurial Candidate, concentrating on small business and immediately removing the many barriers ... Get more on HelpWriting.net ...
  • 66.
  • 67. Kennedy V Nsw Minister For Planning CASE NOTE: KENNEDY V NSW MINISTER FOR PLANNING [2010] NSWLEC 129 I INTRODUCTION In this case, Kennedy v NSW Minister for Planning [2010] NSWLEC 129 the plaintiff is identified as Roy "Dutch" Kennedy on behalf of Sandon Point Aboriginal Tent Embassy and the defendant is the NSW Minister for planning . The case was heard in the NSW Land and Environment Court by Justice Biscoe. The applicant is lodging a review, and thus challenging the grounds of the original decision in relation to the legality of an administrative decision by the Minister for the Stockland's Developments Pty Ltd. II MATERIAL FACTS The Sandon Point was considered a potential State Significant site under the State Environment Planning Policy (Major Development) 2005. In April 2006, the Minister authorised Stockland and Anglican Retirement Villages to submit a concept plan for the development of Sandon Point, Wollongong. The concept plan was approved in December 2006. In November 2007 the Minister's approval was challenged in Walker v Minister for Planning [2007] NSWLEC 741, 174 LGERA 127 due to the Minister's failure to take in to consideration the principles of ecological sustainability, specifically, climate change and flooding. The Court of Appeal found the Minister guilty of failing to consider public interest in the concept planning stages and made it mandatory to be considered in the development approval stage. In mid–2008, an amended concept planning including additional climate change information ... Get more on HelpWriting.net ...
  • 68.
  • 69. Quote Approval In Interviews The practice of quote approval in interviews with politicians and their campaign officials is becoming more common as the constant need for information allows sources to dictate the terms of interviews. Case study 2–A presented by Patterson & Wilkins (2014, p. 37) is concerned with the ethical implications of allowing government officials use quote approval in their interviews and how quote approval affects the reliability of information. Quote approval is a practice that is relatively harmless when omitting parts of quote doesn't change its meaning, but quote approval also sets a dangerous precedent that could lead to more governmental control over public information and the press. Micro Issues First, journalists need to provide citizens ... Show more content on Helpwriting.net ... The freedom of expression is granted unconditionally on the grounds that it is used to do moral good, and placing the needs of a few politicians over the general public is not morally good (Patterson & Wilkins, 2014, p. 38). Bending the truth to benefit the campaign or image of a public figure is deceiving the public regardless of the information being withheld. Citizen journalism heavily influence quote approval since many politicians have misspoke when speaking "off the cuff" with citizens and damaged their public image. Quote approval is used to assure that these situations do not occur and hurt polling numbers, but quote approval could be considered to be breaking the ethical news values of accuracy and community (Patterson & Wilkins, 2014, pp. 35–36). Conclusion In conclusion, quote approval can blur the lines between ethical and unethical journalism depending on the degree of alteration to a quote. Altering quotes can be ethical if it only makes the quote more concise and easy to understand, but there is a fine line between altering for readability and altering the meaning. Quote approval is a slippery slope that could lead to public figures and government officials controlling the flow of information, and the implications of a news media controlled by the government are extremely ... Get more on HelpWriting.net ...
  • 70.
  • 71. Task 2 Approval (PEP) 3 weeks of voluntary work until PEP Task 2 Approval (17th March – 6th April) 300 working hours of PEP (during semester 1, winter break, semester 2, 2016) Although I set working hours whilst on PEP, sometime I was required to be flexible with the time schedule to complete some tasks sooner for further processing, and this definitely challenged me especially during the assignment week at uni. For instance, if someone from the Mind Smart Guides Focus Group couldn't attend a session, I still needed to reschedule with him or her individually to cover his/ her task. However, this even turned out to be a good opportunity to interact with group member(s) personally, which lead them to be more engage freely with the research investigator beyond ... Get more on HelpWriting.net ...
  • 72.
  • 73. Pros And Cons Of School Board Approval Enterprise City Schools has a simple hierarchy regarding the structure of the Enterprise High School's Athletic Department. All major decisions require school board approval. However, Some of the day to day decision need only the approval of the principal or athletic director. The school board meets once a month on the third Tuesday of every month. Requiring all major decisions to have school board approval has its pros and cons. One major pro is coaches, the administrators must be organized and play proactively to get things accomplished. A con is that a decision may take a month to get made. The best way to differentiate between what decision require whose approval is if the school is required to sign a contract, it will need school board ... Get more on HelpWriting.net ...
  • 74.
  • 75. Application For Approval Of Research Activity 14.1. Appendix I – Application for approval of research activity RAD Form APPLICATION FOR APPROVAL OF RESEARCH ACTIVITY RETURN the completed form to Jeanette Fifield, jfifield@eit.ac.nz 1. Applicant details 1.1 Name of Applicant(s) Manu Jacob Iype 1.2 Position of Applicant(s) Student 1.3 School and Faculty School of Computing, Faculty of Business and Technology 1.4 Contact Phone 0223951712 1.5 Supervisor (if applicable) Prof. Alison Clear 1.6 Project Title Green Cloud Computing 1.7 Project Start Date and Duration 21st March 2016, 15 Weeks 2. Research Outline 2.1 Aims/objectives/hypotheses of project (describe in plain language, free from jargon) The aim of this research is to study the contributions of green cloud computing in reducing the wastage of energy and the operational cost in datacentres hosting cloud services and thereby acquiring the environmental sustainability. The study also considers the benefits that can be gained by both service providers and users by having their services going green. The research focus on achieving the result through different case studies done on the performance of network devices and hardware's with and without going green. 2.2 Participants (include information on the participant population, inclusion and exclusion criteria, number and age range of participants, method of recruitment and any payment or reward offered) NA 2.3. Explain the data collection methodology (submit questionnaires, interview / focus group ... Get more on HelpWriting.net ...
  • 76.
  • 77. Application Of Planning Approval And Building Permit Since the proposal is required to apply for a change of use on land, from dwelling to a food and entertainment area, the Local Council of the City of Cockburn needs to grant a planning approval and building permit is to be issued before any use and construction work are to commence. The proposal of a dwelling area to be redeveloped as a new tavern or restaurant with an outdoor entertainment area requires being in the correct zone to avoid being deemed of refusal by the Council. According to the Town Planning Scheme No. 3 (TPS 3) of the City of Cockburn (City of Cockburn 2014), the permitted zones found on the Scheme map are to be in the Regional Centre, District Centre, and Light and Service Centre. Planning Approval Process A planning ... Show more content on Helpwriting.net ... The MRS Form 1 is a request form to start development for the Local Council to evaluate and inspect the proposed development. Additionally, a copy of Certificate of Title with Diagram and Strata Plans are also to be submitted with the approval form. These could be acquired through the Landgate website of the Government of Western Australia (www.landgate.wa.gov.au). The Certificate of Title distinguishes the property ownership, survey plans, and any notices and warnings against the title (West Australian Land Information Authority 2015). A Strata Plan covers the sketches of the building, lot sizes, title details, unit entitlement and common property, and any notices and warnings over the property (West Australian Land Information Authority 2015). It would be easiest to order online through the Landgate website with a cost of $24 for both (West Australian Land Information Authority 2015). The only details needed to order are: the street address, lot number, or title number, a debit or credit card, and an email address (West Australian Land Information Authority 2015). Another requirement is a full written account, which includes a detailed development of the proposed development of the building, a justification of the change of use on the building, and a compliance agreement with the City of Cockburn TPS 3, Residential Design Codes, ... Get more on HelpWriting.net ...
  • 78.
  • 79. FDAApproval Process FDAApproval Process It is commonly documented that every drugs and medical devices brings some risk or side effects. As a matter of fact, every year roughly approximately 1–2 drugs and 6–8 medical devices are discontinued from the U.S. market because of safety issue. Nevertheless, the FDA is charged with assessing the protection and value of medical devices and drugs assessing the advantages versus danger of every merchandise. Nonetheless, the FDA authorization procedures that are utilized for drugs and devices may vary extensively through the CDER. For instances the drug expansion program, takes about anywhere from 8 to 10 years, and starts with a few pre–clinical studies that evaluate genetic and safety activity in a variety of animal models. Most manufacturers have to propose to the FDA in advance what is called an Investigational New Drug (IND) request to show outcomes of preclinical testing before it can be tried on humans. Typically studies in humans are carried out in four parts, three of which must take place earlier to the FDA's approval period. The first phase of the study is intended to set up safety, pharmacology, and safe drug dosage for humans. ... Show more content on Helpwriting.net ... The primary goal of Phase II of the study is comprised of patients with a specific disease and what needs to be done to recognize the best dosage. The third phase of the process is set up to look at effectiveness while reducing toxicity. These studies have generated an open data process on the value and pigeonhole for most common short–term critical effects. Phase III is based on the huge, essential experiments that are regularly used for the FDA authorization of a drug. This phase by and large consist of a huge sample size (hundreds to thousands of patients) are use to estimate ... Get more on HelpWriting.net ...