Why Usa Based Abc Company

Why Usa Based Abc Company
Considering that USA based ABC Company is planning to conduct clinical trials in ICH concern
countries by following the ICH and USFDA guideline. The FDA encourages communicating with
them before conducting clinical trial for the rare disease and follow ICH E5 guidance to provide
references for regulatory and development strategies to authorize clinical data gathered in one
region to be used for the evidence of product registrations in another region following the effect of
ethnic factors (FDA, 1998).The regulatory attentions for planning a multinational pivotal phase III
clinical trial for drug used for rare disease (Orphan drug by the FDA) which is touching less than
200,000 US population comprise the subjects enrolled in the clinical trials, clinical trial
investigators, regulatory agencies, institutional review boards (IRB), and ethics committees,
recommending physicians, formularies, and insurance companies. Phase III pivotal study should
base on clinical trial designed and performed to acquire statistically important proof of efficacy and
safety required by the USFDA for NDA approval. It should include examination with the goal to
include statements into the label as well as postmarketing surveillance commitments. The Orphan
Drug Act of 1983 gives intensive as well as flexibility of using a single study and subsidiary
evidence, for example multiple event measures and extrapolation studies to the ABC Company
(Praiser, 2014).
As per the CFR, title 21, section 314.126,
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The Food Safety Policy Of The European Union
Introduction
Everybody loves food, everybody has to eat. Unfortunately not all food is safe for us to consume,
even though it may appear to be safe. There are over 200 known microbial, chemical or physical
agents that can cause illness when ingested(Acheson, 1999). There has to be regulations to keep the
US and EU citizens healthy and protected from these harmful agents in our food. In the United
States, this is where the FDA(Food and Drug Administration) the CDC(Centers for Disease Control)
and the USDA(United States Department of Agriculture) step in. The FDA controls food and drug
regulations, the CDC helps identify pathogen and diseases and the USDA deals with meat and
poultry regulations. In the European Union(EU) a close FDA ... Show more content on
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The 1990s was the decade that Europe was hit with the "Mad Cow" disease crisis that caused a great
number of the EU citizens to distrust their government. In response to this distrust, the government
came up with different studies and initiatives to change and reorganize food safety(Halkier & Holm,
2006)policy. Today, because of the constant race to defend against food–borne illnesses, the
European Union has one of the highest food safety standards in the world. The European
Commission developed an integrated approach to food safety which they call "from farm to table".
The goal is to address all problems in all sectors of the food chain before they get to the consumers
plate. These sectors include: feed production, primary production, food processing, storage,
transport and retail sale. The EU has implemented a number of legislation pieces to achieve this goal
such as: the General Food Law, a new general Food Safety Policy, and the European Food Safety
Authority(EFSA). The European Food Safety Authority provides scientific advice and support to the
authorities who regulate food safety and they also find ways to communicate its scientific finding to
the public. In addition, there are a few other initiatives and agencies that help deal with food safety
such as the Rapid Alert System for Food and Feed.This is a system that very quickly alerts
authorities and the

Public Opinion On European Integration
In the past, citizens held mostly absent minded opinions on European Union politics, but today there
exists great polarization in attitudes about European integration. The apparent rise in
"Euroskepticism" in the post–Maastricht Treaty political environment has been widely discussed
and debated in EU scholarship, and marks a stark change from the elite dominated days bygone. EU
issues have increasingly made their way into the politics of national governments, and subsequently
national citizens have become more thoughtful in their critiques of European integration. In this
paper, I will first discuss the three approaches to explain public opinion on EU integration. Second, I
will explore the impact political parties and elections play in ... Show more content on
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The decline in public support first emerged in the ratification process of The Maastricht Treaty, and
has continued in the present due to changing geopolitical relations, issues with the Euro, and other
cultural, social, and bureaucratic concerns that have irrevocably become apparent to member state
citizens (Hix & Høyland, 2011, p. 109). Finally, the public is holding the EU accountable for the
decisions made for their homes.
Sara Hobolt (2012) presents three approaches to explain public opinion on European integration:
utilitarian, cue–taking, and national identity (p. 3). The first expounds public support based on the
economic implications that arise from European integration, often reinforced through a cost/benefit
analysis (Hobolt, 2012, p. 5). The cue–taking approach rests on the idea that the public relies on
social and political cues to shape their attitudes on the EU because they are mostly uninformed
(Hobolt, 2012, p. 5). The national identity approach emphasizes people's attachment to their country,
and thus their affinity to adopting their country's opinions (Hobolt, 2012, p. 5). If one were to
explain citizen support or dissent for the EU from the utilitarian perspective, there would be
emphasis on trade liberalization. On the national level, public opinion is higher in countries that
profit most substantially from EU

The Passage Of Time Has Resulted On National And...
The passage of time has resulted in numerous political parties around the world that deliberate on
national and international policy. These parties prioritize certain issues over others resulting in the
multitude of party platforms such as Green, Conservative, Liberal Democrat, etc. that are seen in
governments. Some of these parties are tactically suited to maintaining their original stance with
issues that have come up over time. For example, the green parties which have gained relevance
concurrently with environmental issues seem to maintain a fairly steady political stance. Other
parties, however, have long histories of voting and precedence in government that have sustained
over centuries such as conservative and liberal parties. ... Show more content on Helpwriting.net ...
This hypothesis is that of national location. The philosophy behind this political positioning suggests
that in an issue such as European integration there will be more variation seen in countries that have
more diverse social and economic factors involved in policy making. The article suggests that with
this hypothesis that issues will be decided on by parties potentially depending on what is in the best
interest at tat time based on the national feeling that is present in their respective countries. This
hypothesis is certainly well–founded in the idea of European integration as if national interests are
largely in favor of integration it stands to follow that parties and policy would likewise be in favor.
Still, the next hypothesis that is given, the median supporter, also makes sense for parties and
shifting stances. In this parties would generally change their stances just enough to create the most
potential to gather a maximum amount of votes. This would allow parties in the case of European
integration to stick safely to the ideals of their average voter which would potentially allow for the
most representatively accurate ideas to take force. This meaning that if this hypothesis were correct
political parties would correspondingly move towards integration with their average voters'
perspective in mind so as to appeal to the most voters as possible.
Finally, the last alternative hypothesis presented in the article took the stance of parties going one of

What Are The Advantages And Disadvantages Of The Space...
Space manufacturing is a kind of industry which have the characters with high technology, capital
and knowledge concentrated, and with a high entry level. Generally, the support to the space
industry mainly come from the local government. But this situation result in the whole space
economy and industry were divided by several large corporation. The space industry and
manufacturing were influenced mainly by the domestic economy, so many nations choose the
strategy that support domestic manufacturer's development by awarding orders. From the angle of
space supply chain, following introduce the main America, European and Chinese Space "Primes",
"Tier1" and "Tier2". 1.4.1 Space agencies (Primes) Generally, in space supply chain, the "Primes"
refers to ... Show more content on Helpwriting.net ...
As an organization of different Member States, the disadvantage is obvious, difficult to make final
decision, many project must agree with each members. Giant difficultly turn round. 1.4.1.3 CNSA
The China National Space Administration (CNSA) is the national space agency of the People's
Republic of China. CNSA assumes the following main responsibilities: signing governmental
agreements in the space area on behalf of organizations, inter–governmental scientific and technical
exchanges and also being in charge of the enforcement of national space policies and managing the
national space science, technology and industry. Although China's space program has existed since
1956, CNSA is a relatively space agency created in 1993 with the approval by the Eighth National
People's Congress of China when the Ministry of Aerospace Industry was split into CNSA and the
China Aerospace Corporation (CASC). Over the past few years, China's space industry has
developed rapidly and China ranks among the world's leading countries in certain major areas of
space technology,

Orphan Drug Act Research Paper
There have been 5,000 rare diseases that have been identified. The disease is considered rare in the
United States if less than 200,000 people have it. The pharmaceutical industry will not develop a
cure for the disease since it does not affect most of a population. For this reason, Congress passed
the Orphan Drug Act (ODA) in 1983.
Under the Ronald Reagan administration the Orphan Drug Act allows the federal government to
help out in the making of new drugs for these rare diseases. Incentives are given to the drug
manufacturer in order to intise them to find a cure or develop a drug that will help out. To find a
cure can become very expensive and time consuming for the drug companies. There are incentives
given to the drug manufacturers like grant funding, assistance in the drug development, seven–year
patent on the drug post–Food and Drug Administration approval, and so forth. In the end, the drug
company has the better end of the deal.
Some people do not fully understand what orphan drugs are. Orphan drugs are defined as drugs that
have not been developed yet because the need for that drug to be made is not in that of high demand
from the general public. Also, ... Show more content on Helpwriting.net ...
More than 265 of the drugs have been approved by the Food and Drug Administration. Out of these
265 drugs 209 of these drugs are for the use of rare diseases. The increase has been astonishing
taking into consideration from when the Orphan Drug Act was first passed there were only about 15
orphan drugs that were approved.
The Orphan Drug Act has come a long way and has helped many people maintain a long a
prosperous life. For those who have not been so fortunate many of us owe a great deal of thanks to
these people. If these people did not take the sacrifice many more people today would not be here if
it was not for the orphan drugs that were created for people with rare

A Short Note On The 18 Year Mission
Title: Ulysses, the 18–Year Mission
Table of Contents
Page #
1. Introduction
2. Space Craft
A. Components
B. Journey
C. History
D. Launch
3. Objectives
A. Secondary Objectives
4. Partnerships
A. ESA
B. NASA
C. Contribution
7. Future
A. Challenges
B. What we learned
C. Future Missions
8. Conclusion // Summary
9. References
1. Introduction:
Space is made of many secrets yet to be discover, but every day we tend to move closer. However,
due to size of space we will never stop learning. For example, 50 years ago many people thought it
impossible to travel to the moon, but as time continue we realize that nothing is impossible, it just
needs time. Although, the discoveries we have made regarding to space are relative new, the ideals
and concept are not. Most of them come from people such as Galileo or even Leonardo da Vinci
which most of them are over half a century old. Moreover, Ulysses was also an idea that started way
before it was commissioned, but due to the lack of technological advances it had to be put a hold.
However, it was never forgotten. Furthermore, this paper will look at Ulysses Spacecraft, but most
importantly how Ulysses was able to study the heliosphere during its 18 year mission orbiting
around the sun. In other words, this paper will focus on how Ulysses was able to study the region of
space influenced by the Sun and its magnetic field. As well as its discoveries and the partnership
between NASA and ESA which with their collaboration made the mission

Different Applications For Small And Large Molecules
Q.1 Compare and contrast NDA and BLA. Why are there different applications for small and large
molecules?
A small molecule drug approval required a New Drug Application (NDA) because it covered under
Federal Food Drug and cosmetic Act Section 505 while large molecule drug required a Biologics
License Application (BLA) because it covered under Public Health Service Act Section 351.
Compared with conventional small–molecule drugs, products derived from a biological source are
structurally complex, large molecules and involved in different manufacturing processes that require
tight control to ensure their safety, purity, quality, and efficacy. Because of these differences in
respect of the product characteristics and manufacturing process, ... Show more content on
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The regulations regarding BLAs for therapeutic biological products included in 21 CFR parts 600,
601 and 610.
Form 356h is a harmonized form, and a sponsor can use it for NDA, BLA and Abbreviated New
Drug Application (ANDA).
Drugs are nominated as orphan drugs for those diseases with patient population of less than 200,000
in the US. The FDA has given special provision for the development, marketing approval and
marketing of orphan drugs under 21 CFR Part 316.The Orphan Drug Act provides incentives to
organizations to research and test drugs because it have limited commercial returns due to the small
size of the patient group. Companies are taking commercial risks so FDA is providing assistance in
the forms of NDA fee waivers, tax credits for clinical research, and grants for the research. The FDA
also provides market monopoly to the organization to market the drug for seven years. The office
also works on rare disease issues with the medical and research communities, professional
organizations, academia, governmental agencies, industry, and rare disease patient groups. The
Orphan Grants Program from FDA has been used to bring more than 45 products in the market.
21CFR 316 gives FDA right to revoke orphan drug designation if they found that untrue statement
regarding material fact or drug is not eligible as an orphan drug and withdraw marketing monopoly.

Near Earth Object Essay
Topic #2: Near–Earth Objects
Though not mentioned in the news and talks of society, near–earth objects (NEOs) are an
international threat for countries worldwide. A NEO is a meteoroid, asteroid, or comet pushed by the
gravitational attraction of nearby planets, potentially entering the earth's orbit and thereby pose a
danger of collision. Space agencies around the world express the universal outlook that NEOs must
be somehow controlled or mitigated in their magnitude of impact. Austria, along with many
countries, expresses deep concern over this issue and is more than willing to participate in this
world–saving quest. As a long–standing member of COPUOS, the European Space Agency (ESA),
and other intergovernmental organizations, Austria ... Show more content on Helpwriting.net ...
Aside from Austria's membership in the ESA, there is rapid advancements in technology within the
country, leading to its growing intention of joining SMPAG as an individual member in the near
future. In all ways possible, Austria devotes to the protection of Earth against NEOs.
In regards to the solutions for this issue, Austria welcomes the assistance of other countries and
recommends the development of a system to regulate the responsibilities of countries on such
problem. Austria believes countries should have the choice of applying for special status (or partial
special status), a request for help from the more technologically advanced member states. Larger
and more capable countries will be presumed as responsible for the NEOs affecting them if they
choose not to apply for assistance. The UN–SPIDER is precisely the platform to use for the sharing
of NEO information and the distribution of responsibilities. Concerning the method for mitigation of
NEOs, Austria appreciates the efforts countries have placed into the many suggestions, but stands
against the use of nuclear power in the proposed blast detection method. In forms of health, the
development of nuclear technologies are associated with many health risks; the release of radiation,
being one of the most prominent dangers. Not to mention, the financial costs of nuclear power is a
sum of many which many

The Space Of Space Exploration
Space exploration has opened up so many new aspects to what is really out there and we have
accomplished many things in terms of discovery and proof. There are issues involved with space
exploration, though, such as space debris, astronaut safety, and the theory of space exploration really
being a mission to find an alternative livable space if Earth ever becomes uninhabitable.
Understanding the real reasons why we are going to such great lengths to find life in space could
change the outlook on our future. For a long time, our endeavors in space exploration were based
purely in the name of science. When we made our first accomplishments, we made history. One of
our most historical accomplishments was NASA's mission to the moon. Buzz Aldrin was a lunar
module pilot on the spaceflight Apollo 11 in 1969. He went alongside Neil Armstrong as the second
man in history to step foot on the moon. In his 2013 article in Astronomy, Buzz states, "Looking at
Earth from that perspective, everything I knew and loved lay suspended overhead, residing on a
small, fragile, bright blue sphere engulfed by the blackness of space" (p.24). This sight that he
explained not only changed his perspective, but brought unspeakable awe to humanity's front door
and changed our entire view of Earth. From that moment when these men landed on the moon, and
we saw our home from that distance, history was made. The successful outcome of this mission
opened up a whole new set of possibilities into the

Animal Testing Should Not Be Banned
Picture yourself applying your favorite make–up or taking medicine prescribed to you by your
doctor, and ask yourself, how do you know it 's safe? Have you ever wondered what goes in to make
sure that cosmetics and medicine isn't lethal? A majority of ensuring items such as medicine and
cosmetics are safe to use is done by testing the medicine and cosmetics on a multitude of different
kinds of animals (Abbott 1). Animal testing saved many lives in the past ("Animal", par.7) but as
science bred new methods, much like in vitro, which uses human cells cultivated in a lab, the
potential for a replacement to animal testing arose (Abbott 1). Whether or not one is more effective
than the other has been a hot topic for years, and multiple studies ... Show more content on
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If the animal shows any irritation or damage, it is possible to decide whether or not the chemical is
permissible to use in consumer products. Experiments such as these are performed to test whether or
not items like mascara are safe for humans to use depending on the reaction of the animal (Abbott
1). Many of these experiments require hundreds of animals to get a clear result (Abbott 1). As
animal testing progressed throughout history, health organizations and industries started the
initiation of alternative tests, which involve a number of different approaches that do not involve
animals. Finding alternatives to testing with animals wasn't a main priority for many, until the
European Union initiated a program called REACH, which stands for Registration, Evaluation and
Authorization of Chemicals (Abbott 1). This initiative required European countries to document the
30,000+ chemicals that are used in experiments to measure the safety of cosmetics and medications.
Issuing this initiative caused many agencies to become concerned with how much it would cost to
go through all of these animal tests and document each chemical (Abbott 1). Due to this reason,
many began to implement the new alternatives that were presented to many agencies. These
different types of alternatives all stem from in vitro procedures. In vitro testing uses cells that are
cultivated in a lab to form different tissues for scientists to test. For example, the different

The Terms Of Return On Investment Essay
Current Situation Overall in terms of return on investment (R.O.I.), market share, and profitability,
Pfizer performed well in 2014. Pfizer generated a 7.01% R.O.I., a 28.3 % return on equity (R.O.E.),
and a 12.78% return on assets (R.O.A.). In the last four years shareholders have witnessed their
shares more than double totaling: 23, 858, 089 shares. And as a matter of fact, in terms of
profitability, Pfizer has generated more revenue than any other pharmaceutical company in the
world. Pfizer has a gross profit margin of 81.42%, an operating profit margin of 29.44%, and a net
profit margin of 42.65% (CSI Market, 2014).
Strategic Posture
Strategic posture is an approach company leaders take in applying a business's strengths to the
current and long–term needs of the marketplace. Formulating a strategic posture is part of the
broader strategic planning process, when managers collaborate to develop the vision, goals and
strategies for a business in the foreseeable future. By recognizing the nature of a strategic posture,
one can lead their company more effectively (Kokemuller, n.d.).
Pfizer's mission is to, "be the premier innovative biopharmaceutical company." Some of the
objectives Pfizer aims to accomplish include: developing new therapies for inflammation and
immunology, cardiovascular and metabolic diseases, neuroscience and pain treatments. The
corporations' current strategy is dependent upon: innovation, value maximization, social respect, and
cultural ownership.

Pros And Cons Of A Pharmacist
From my childhood memories, I distinctly recall one occasion when my grandmother took me with
her into the building marked "Pharmacy" where she used to work at. While I waited for my parents
there, I was admired to see how my grandmother worked with her patients. When a little boy came
in with his parents, grandma smiled brightly at him and gave him a candy to make him feel
comfortable. At some point my grandmother looked like a medical doctor as she patiently asked for
the boy's symptoms of illness and about used drugs for recovery then when she gave the best
appropriate drug explained the usage of the medicine to her parents in a simple way.
After experiencing the whole day of grandmother's work, I discovered that a pharmacist's job leaves
very ... Show more content on Helpwriting.net ...
Working as a pharmacy assistant helped /enables/ me to become a more creative thinker, an good
adviser, and a friend. Like every career field, the pharmacy has its pros and cons. While working in
retail pharmacy place I understood the advantages and disadvantages of pharmacy field. Pharmacist
must advice their patient what medication is best for patient to achieve quick recovery of illness
after considering many factors including patients medicine usage history and any other health
problems patient have. Aside from physical demands, there are strong mental demands needed to be
a pharmacist. You have to be on top of your career as a pharmacist. Every. Single. Day. The very
nature of this field means you will be the go–to person for solving problems./critical thinking/.Not
only will you answer the questions of dozens of patients, you will help other healthcare
professionals who work with you.The role of a pharmacist is unquestionably one of immense
responsibility. Handing people medicine over the counter /OTC/ isn't the only part of your job. As a
pharmacist your duty is

Essay On Outer Space
Topic #2: Long–Term Sustainability of Outer Space Activities
As a long–standing member of the COPOUS, the European Space Agency (ESA), and various
intergovernmental space organizations, the Republic of Austria applauds the significant
advancements of space technologies, yet remains deeply concerned about the long–term
sustainability of space in relation to the growth of human activities at such exponential rates. Of
equally as great importance as the threat of terrorist attacks, the happenings in outer space must be
controlled while keeping in mind the provisions for the future, especially in forms of space
exploration. Such continuous pursuits of the different nations are aiding the increase in space debris,
radio interference, and space ... Show more content on Helpwriting.net ...
It has developed a multi–segment Space Situational Awareness (SSA) program, one in which
Austria participates greatly in its space weather research segment. As well, Austria has a Satellite
Laser Ranging for Space Debris Monitoring, one of the key technologies which allow for their
extensive participation. With deep concern, Austria has cooperated with many countries last year in
the proposal of a set of guidelines along with a refined and renewed work plan for the Working
Group on the Long–term Sustainability of Outer Space Activities of the Scientific and Technical
Subcommittee. And in the same year of 2016, Austria has established an European Space Education
Research Office for space education for Austria's future generations.
Through devoted research, Austria proposes a few potential resolutions and calls other countries to
come to its assistance. The satellites' use of radio waves to receive commands from earth and
transmit information can be disrupted by nearby systems operating on the same frequency. Austria
believes that countries should develop a world–wide, unified platform to share information on their
actions in space to better coordinate activities. For example, Austria believes all countries should
commit to participation in the UN–SPIDER (United Nations Platform for Space–based Information
for Disaster Management and Emergency Response), a platform which facilitates the use of

Exoplanet Research Paper
Exoplanets are any sort of planet that inherently orbits a star. In this context, the sun cannot be
recognized as a star that will be orbited around. Exoplanets vary in size that can be smaller than
Earth or even larger than planets such as Jupiter and Saturn. Exoplanets are capable of orbiting their
star at various distances. The exoplanet is dependent to certain areas that navigates the distance
between it and the star that it is orbiting. Orbiting at the perfect distance depicts the exoplanet in the
star's "habitable zone." Precisely meaning that the temperature is just right that allows water to be in
its liquid form and the exoplanet might be capable of supporting life.
There are certain things to keep in mind while exploring exoplanets. ... Show more content on
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This will allow scientists to analyze whether or not there are planets that are habitable and can
support life. The telescope will be one of the most vital and innovative technology used to
understand evolution and life. The production of the telescope is a collaboration between NASA, the
Canadian Space Agency and the European Space Agency. In terms of the structure of the telescope,
there are certain innovative technologies used on it that enhances the technological advancements
and development of the telescope. The mirrors used are made from beryllium, which is very light–
weight. The telescope also has a very large multi layered sunshield, which reduces the heat being
absorbed from the sun. Another key innovation is that various instruments in the telescope,
including spectrometers and cameras, have detectors that can perceive various signals.
NASA's discovery of exoplanets was released in February of 2017. It publicized the finding of
several planets that were primarily similar to the size of Earth. These planets were established in the
"habitable zone" of a singular star, which is called TRAPPIST–1. The system includes seven worlds
that all have the possibility of containing water and various resources to acknowledge life. Future
studies on the system will allow humans to examine the conditions on of the system and

Space Exploration Persuasive Essay
The concept of space exploration was first introduced to the American public in 1961 when
President John F. Kennedy famously stood before congress and vowed that America would put a
man on the moon "within the decade." With hopes of defeating the Soviet Union in the "Space
Race" and gaining a leg–up in the Cold War, NASA funding reached its all–time high in 1965–1966
when about four percent of the federal budget was devoted to exploring space. Since then however,
funding dedicated to exploring space has nose–dived to about one–half of a percent of the federal
budget (Tyson), with plans to cut that figure by an additional $260 million in 2017 (cite NASA
funding cuts). Experts in the space–sciences field argue that increased funding in space exploration
would re–ignite the American economy and return America to the scientific prominence it was once
known for, while, on the other end of the spectrum, naysayers suggest that exploring space is an
economic sink–hole that the United States can no longer afford to deposit to given its own earth–
bound troubles. The biggest affect increased space exploration would have could be its change on
the education landscape. In 1998, NASA scientists Adriana Ocampo, Louis Friedman, and John
Logsdon explored NASA's effect on education in their article, "Why Space Science and Exploration
Benefit Everyone." Though their writing is nearly 20 years old, Ocampo, Friedman, and Logsdon
explain why handcuffing NASA creates a "brain drain" in America –

Key Regulatory Challenge For The Pharmaceutical Sector
Full name:
NUID number:
Husky e–mail:
Start term in the program:
The number of credits completed prior to the Spring 2014 term (this includes Winter 2014 course):
GPA (as of the start of the Summer 2014 term):
Essay:
1. What is a key regulatory challenge in your home country?
The key regulatory challenge for the Pharmaceutical sector (for Marketing Authorisation holders
and Sponsors of clinical trials) in European Union is the new European Union Pharmacovigilance
legislation to submit the information on Individual Case Safety Reports (ICSRs) related to medicinal
products authorised in the European Union (EU) and investigational medicinal products (IMPs)
studied in clinical trials authorised in the EU ... Show more content on Helpwriting.net ...
To ensure accurate updated information, EMA develop constantly new legislation.
In 2012, it became mandatory for Marketing Authorization Holders (MAHs) which maintain
products in the European Union, whether centralized, decentralized, Mutual recognition or national
to provide detailed structure data within 15 days for all human medicinal authorized products to
Extended EudraVigilance Medicinal Product Dictionary (xEVMPD).
The latest changes in the Pharmacovigilance regulation issued on January 31, 2014 with the legal
notice on the implementation of article 57(2) of Regulation (EC) No. 726/2004. MAH's should
submit the updated information of Authorised product by 31st December, 2014.
MAHs shall electronically notify to the Agency information or any amendments to the terms of the
marketing authorizations following variation, transfer, renewal, suspension, revocation or

withdrawal no later than 30 calendar days from the date of which the amendments have been
authorized. Moreover, more

Taking a Look at BioMarin
1. Background
BioMarin is a biotechnology company headquartered in Novato, California and with operations in
Europe, South America, USA and Asia. BioMarin originally began developing carbohydrate
enzymes for rare diseases. Their first candidate drug was Aldurazyme® which is currently being
used to treat patients of Mucopolysaccharidosis (MPS–I). MPS–I patient census consists of about
3,400 patients in developed countries; 1,000 of which reside in the United States of America.
Because of the rare nature of this condition and the rareness of other conditions being treated by
BioMarin, they are considered an orphan drug company. Receiving orphan drug designation has
resulted in BioMarin gaining certain advantages from the FDA such as: seven year exclusive period
on marketing after a drug has been approved and tax incentives. As such, BioMarin has not
necessarily faced competition in the therapeutic areas of their approved products. BioMarin was
founded as a subsidiary of Glyko Biomedical in 1996 and started operations in 1997. While Glyko
provided the initial start–up funds, BioMarin also sold 2.5 million common stock to its founders.
The company has a history of success in fundraising. Examples of some key financing activities
experienced a few years after inception include private placements to independent investors and
Glyko Biomedical in 1999 worth $26 million and a 50:50 joint venture with Genzyme in 1998 worth
$30 million. BioMarin raised a combined sum of $58 million

Orphan Drug Market Development And Manufacturing Of Products
Sanofi Genzyme is a branch of the Sanofi Corporation that specializes in the development and
manufacturing of products to treat a variety of rare diseases. The Allston Landing Facility (ALF)
currently produces a single enzyme replacement therapy which treats patients with Type 1 Gaucher
disease. This treatment falls within the classification of an Orphan drug which is a drug or biologic
that treats a patient population of less than 200,000 within the United States. There is an entire
segment of the pharmaceutical industry comprised of companies that develop and manufacture
treatments for rare diseases. The Orphan Drug market has a projected Worldwide 2020 sales forecast
$178bn with a compound annual growth rate (CAGR) of 11.7% per ... Show more content on
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In addition, once a patient begins a treatment that improves their condition there is a low likelihood
that the patient will stop that treatment. Also, the low success rate of drugs from development
through FDA approval decreases the chance that a competitor will develop an alternative treatment.
The bargaining power of the customers within the Orphan Drug patient population is classified as
medium/low. While patients are price sensitive; the cost of treatment for most is subsidized by either
health insurance or government funding and therefore the price of these treatments are typically very
high. The average per patient on an orphan drug in the year of 2014 was calculated to be over
$110,0001. While the average cost is currently high, this has become and increased area of scrutiny
worldwide and many governments are enacting price control within the industry, eating away at
potential profits.
Once a company has successfully developed an orphan drug and gained FDA approval, the process
to build and operate a manufacturing facility can be extremely costly. This is driven by the fact that
the bargaining power of the supplies is medium/high. This classification is because of the extreme
regulations that exist for not only the equipment, but also the raw materials used within the drug
manufacturing process. The environment causes companies to create stringent supplier

The Expansion Of A Nation State Beyond The World
As Europe climbs into a semi–peaceful time, many powers look for a way to expand their names
beyond their claimed territories. Splicing through the 1850's and beyond European powers spread
through Africa, Australia, China, America, Japan and anywhere they could find a resource to be
exploited. Many great discoveries and advances appeared due to these colonization's and
expeditions, scientifically and historically. Imperialism is the expansion of a nation state beyond
their position, whether it be through military, political or economic powers. This idea spread
throughout Europe and sparked the expansion into many countries that neither were expecting it or
even welcomed it. The motives that fueled the spark of colonization were economic, ... Show more
content on Helpwriting.net ...
As countries settled in unknown places, learning about the plants, wildlife, and lands made them
more powerful than the countries who did not settle there. They were able to hold that information
over their enemies. Notably, the French are known for their geographical influences in their colonies
and explorations. The French colonization in Mexico is a major area they gained power. The many
explorations and documentation the French scientists massed are invaluable knowledge then and
now. Scientists such as Alexander von Humboldt and Henri de Saussure paved the way for many
more to document the lavish lands of Mexico. However, their work was deterred by off limit areas
and questions of legitimacy in their findings. These geographical advances made it possible for the
French to publish volumes of scholar level information. This, for any country, is an area that can
hold much power. Geographical influences prevailed throughout Africa with many different
European powers claiming her. In the early days of European colonization Africa was seen as a
purely territorial and prestigious land to settle. The idea was to take her before anyone else did. This
gave way to much geographical reasoning for colonization. In the words of historian George N.
Sanderson, "Until the 1870's, Africa as a whole had been a purely geographical concept, of no
practical relevance to the European politicians and merchants concerned with the continent." (2008,

After Two Decades Of Gathering Promising Data, Nasa And
After two decades of gathering promising data, NASA and collaborating space agencies have
decided that they want to send three brave volunteers to assess the viability of colonizing Saturn's
largest moon, Titan. Initially, there is publish outcry concerning the permanent relocation of three
people to a distant planet. In addition, the science community raises concerns regarding space travel
of that distance and the prolonged exposure to radiation that the crew would experience. After
several years, three volunteers make themselves known and NASA begins training them. The public
and science community are concerned with physical health of the volunteers while travelling and
while they reside on Titan. However, the mission's security ... Show more content on
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This network involve massive radio antenna located near Barstow, California, Madrid, Spain, and
Canberra, Australia. Typically, a 70–meter wide antenna is used to receive radio communication
from the Cassini Mission. Sometimes smaller antenna are used in conjunction to increase the signal
strength (JPL Archive). The positioning of these antenna allows Earth to potentially have a line of
sight to anything NASA is trying to communicate with. (JPL, Deep Space Network). Any
communication between NASA and the Cassini Orbiter are done through radio wave, which can
range in length from fractions of an inch to about 100 kilometers.
The Cassini Orbiter has been in orbit around Saturn, and is used to collect data such as
electromagnetic spectrum analysis, particle analysis, and radio wave analysis. It is equipped with 12
science instruments, which include an ultraviolet imaging spectrograph, a cosmic dust analyzer, and
a radar. The Cassini Orbiter is 6.7 meters tall, and 4 meters wide (NASA, JPL). It is powered by
radioisotope thermoelectric generators. Initially the Cassini Orbiter was meant to discover more
information regarding Saturn's atmosphere, its satellites, its rings, and its magnetosphere. Two
previously unknown satellites, Methone and Pallene, were discovered almost immediately upon
arriving. Since then, the orbiter has found evidence of liquid water jetstreams on Enceladus, and has
been able to detect other interesting details about

The Causes And Impacts Of The International Space Station
The International Space Station commonly known as the (ISS) is a large spacecraft that orbits
around Earth. This space station serves as a home for the crews of astronauts and cosmonauts. The
space station is also a unique science laboratory. Several nations such as Canada, Japan, the Russian
Federation, the United States, and eleven Member States of the European Space Agency (Belgium,
Denmark, France, Germany, Italy, Netherlands, Norway, Spain, Sweden, Switzerland and the United
Kingdom) worked together to build and use this space station. The space station is made of parts
that were assembled by astronauts, in space itself. NASA is using this space station to learn more
about the living and working conditions in space. These discoveries will help make it possible for
them to find out if it is feasible to send humans farther into space than ever done in the past.
Political:
The International Space Station was first considered in the waning years of the Cold War. A space
station called Mir was prepared to be launched by the Soviet Union, which went into orbit in 1986.
The United States wanted to match its rival.During his 1984 State of the Union address, President
Ronald Regan announced his plans for a U.S led project. Russia was invited to join the space station
by the United States when they decided to expand their international partnership, after the collapse
of the Soviet Union in 1993. Eugene Skolnikoff, professor emeritus of political science at the
Massachusetts

Animal Testing : Necessary Procedure Or Outdated Experiment?
Animal Testing: Necessary Procedure or Outdated Experiment? Picture yourself applying your
favorite make–up or taking medicine prescribed to you by your doctor, and ask yourself, how do
you know its safe? Have you ever wondered what goes in to make sure that makeup or medicine
isn't lethal? A majority of making sure if things like drugs and make–up are safe is done by testing
the drugs and cosmetics on different kinds of animals (Abbott 1). Animal testing once saved many
lives ("Animal", par.7) but as science progressed new methods, much like in vitro which uses human
cells cultivated in a lab, were found that had the potential to replace animal testing (Abbott 1).
Whether or not one is more effective than the other has been a hot topic for years, and multiple
studies have been done to compare the two to each other. I believe that animal testing is a method
that is no longer needed, because there are alternatives to animal testing that can achieve the same
results without causing harm to animals. One of the main components that is not known well when it
comes to having a discussion in animal testing is what exactly happens in animal testing and what
the alternatives to animal testing are. Animal testing takes potential chemicals that industries want to
introduce in cosmetics or medicine and injects them into animals to test their reactions to the
chemical (Abbott 1). One example is called the draize test, which injects a needle directly into a
rabbit's eye to test the

The Approval Process Of Biosimilar Products Within The...
There are similarities and differences among the regulations addressing the approval process of
biosimilar products within the United States, the European Union, South Korea and Japan. This
paper will attempt to identify these similarities and differences and determine how best practices can
be leveraged among the associated regulatory bodies.
The regulatory responsibility of the Food and Drug Administration (FDA) dates back to 1906 with
the passage of the 1906 Pure Food and Drugs Act. "The Pure Food and Drugs Act, prohibited the
interstate commerce in adulterated and misbranded food and drugs". (1) The administration adapted
its current name in 1930. A major aspect of the FDA's mission is to "protect the public health by
ensuring the ... Show more content on Helpwriting.net ...
(4)
"Animal studies (including the assessment of toxicity)" (4)
"A clinical study or studies (including the assessment of immunogenicity and pharmacokinetics or
pharmacodynamics) that are sufficient to demonstrate safety, purity, and potency in 1 or more
appropriate conditions of use for which the reference product is licensed and intended to be used and
for which licensure is sought for the biological product". (4)
The following guidance is provided for the selection of reference product:
"The biological product and reference product utilize the same mechanism or mecha¬nisms of
action for the condition or conditions of use prescribed, recommended, or suggested in the proposed
labeling, but only to the extent the mechanism or mechanisms of action are known for the reference
product" (4)
"The condition or conditions of use pre¬scribed, recommended, or suggested in the labeling
proposed for the biological product have been pre¬viously approved for the reference product". (4)
"The route of administration, the dosage form, and the strength of the biological product are the
same as those of the reference product" (4)
"The facility in which the biological product is manufactured, processed, packed, or held meets
standards designed to assure that the biological

The Body Politic : The Removal Of Agency And The Struggle...
The Body Politic: The Removal of Agency and the Struggle for Power The demand for sexual
services is a universal constant in human society–from the sexual slavery of the Indo–Asian colonial
period, to contemporary Canada, the relation between sex and power is an undisputed fact.
Prostitutes and concubines are and were people who struggled with power historically due to their
positions in society and their occupations; they have struggled for political access, for their own
safety, and for their freedom. By contrasting modern prostitution with concubinage in colonial Asia,
I will show how systems of justice operate in sexist and racist policies in order to regulate and
restrict the agency of sex workers and concubines. From the destruction ... Show more content on
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By not creating laws–and by outlawing practices which made prostitution safer for sex workers,
such as bawdy houses–the Canadian government presented the identity of the sex worker as being of
low worth and ultimately increased their vulnerability. In her examination of colonial concubines in
Asia, Stoler explored what the role of concubine entailed for colonized women: such as being
"guides to the language and mysteries of the foreign society" (116) for the European men. They
were to treat their illnesses, and essentially meant to "[keep] them alive" (116). By constructing
concubines as tools instead of people–to be used for medicine, socialization, sexual services, and
whatever else the man needed–the colonizers depersonalized the indigenous women they so clearly
required. They were in high demand–places with uneven sex ratios, such as North Sumatra, had
"intense competition" for women, sometimes resulting in assaults (220)–and yet completely
disregarded by the state as people with inner lives, friendships, families, and interests. In the context
of the colonial period, which was based on hierarchies of race and superiority, it isn 't surprising that
the colonizers would proliferate this view of the indigenous women. Colonial power was based on
the

Fda Drug Review Process
Comparison USA FDA, Health Canada, and EMA The regulatory body in USA is the FDA, in the
European Union the EMA, the European Commission and the national authorities of the EU
member states and in the Canada the Health Canada handle the drug review processes. Each agency
has their own distinctive approaches to approve drugs biologics and medical devices. The
globalization of the pharmaceutical industry, harmonising the drug regulatory approval process of
the US FDA and EU EMA, and Health Canada is essential to speed up the progress of new
treatments. The main goal of all agencies is to put a drug in the market in safe, efficient and faster.
We will examine here the agencies' approval process time frame and other drug approval pathways.
USAFDA ... Show more content on Helpwriting.net ...
If a new drug has potential therapeutic value that outweighs the risks an applicant needs to submit
drug submission for new drug or biologic to the Health Canada's Health Products and Food Branch
(HPFB) to pursue a review and, ultimately, regulatory approval (Health Canada, 2016). Canadian
regulations need preclinical and clinical trials to get a marketing approval in Canada. The HPFB
assesses and observes the safety, efficacy and quality of drugs used for human and animal, medical
devices, natural health and other therapeutic products. A manufacturer may apply for the Generic
product via Abbreviated NDS (ANDS). In Canada, medical devices are divided into four classes
based on the level of risk connected with their use, Class I devices present the lowest potential risk
like thermometers that do not require a medical device license. Class II, III and IV devices required
a medical device license to sell the products legally in the

Cost Efficiency : Private Vs. Government Space Industry
Matthew Epple
Prof. Beyli
Composition 1 OQM
1, December 2016
Cost Efficiency: Private VS. Government Space Industry
Many Americans have grown up in a world that has conquered space. They spent their time in
elementary school reading about moon landings in their history books and watching countries work
together to build the International Space Station on the news. Though previous American and
Russian space programs pioneered engineering technologies; such as reusable rocket boosters and
multiuse shuttles. Recently NASA has made a decision that has defined the future of space travel.
This decision was to expand the growth of the free market space industry. Though polarizing, the
evolution of the free market space industry is a positive occurrence for the world because private
space corporations are more cost efficient then government space programs.
In order to provide a proper cost comparison, the statistics will include programs and countries from
around the world. Each company is directly launch capable, meaning that the program can build,
launch, and retrieve any objects sent into orbit. Examples of such eligible programs are the French
CNES, American NASA, American ULA Company, and American SpaceX Company. This report
will average all applicable yearly budgets as well as individual mission and launch costs for each
program and company. Note that not all countries give numbers for specific areas that this report
covers but there is still a healthy variety of information

Aircraft Continuing Airworthiness Record System
Aircraft continuing airworthiness record system At the completion of any maintenance, the
certificate of release to service required by point M.A.801 or point 145.A.50 shall be entered in the
aircraft continuing airworthiness records. Each entry shall be made as soon as practicable but in no
case more than 30 days after the day of the maintenance action. The aircraft continuing
airworthiness records shall consist of: an aircraft logbook, engine logbook(s) or engine module log
cards, propeller logbook(s) and log cards, for any service life limited component as appropriate, and,
when required in point M.A.306 for commercial air transport or by the Member State for
commercial operations other than commercial air ... Show more content on Helpwriting.net ...
AMC M.A.305 (d) (4) and AMC M.A.305 (h) Aircraft continuing airworthiness record system The
current status of service life–limited aircraft components should indicate: i) for components subject
to a certified life limit: the component life limitation, total number of hours, accumulated cycles or
calendar time and the number of hours/cycles/time remaining before the required retirement time of
the component is reached; ii) for components subject to a service life limit: the component service
life limit, the hours, cycles or calendar time since the component has been restored back to their
service life and the remaining service (hours, cycles, calendar time) life before the components need
to undergo maintenance. Any action that alters the components' life limit (certified or service) or
changes the parameter of the life limit (certified or service) should be recorded. AMC M.A.305 (h)
Aircraft continuing airworthiness record system When an owner/operator arranges for the relevant
maintenance organisation to retain copies of the continuing airworthiness records on their behalf, the
owner/operator will continue to be responsible for the retention of records. If they cease to be the
owner/operator of the aircraft, they also remain responsible for transferring the records to any other
person who becomes the owner/operator of the aircraft. Continuing airworthiness

The Fda's Global Unique Device Identification Analysis
The FDA has established a unique device identification (UDI) database to enhance the identification
of medical devices from point of manufacture through delivery to the end user. This guideline
covers medical devices Classes I, II, and III (FDA 2014), where Class I poses the lowest risk to
patient and Class III carries the highest risk. When fully implemented, the label for the majority of
medical devices will contain a unique device identifier (UDI) in a human and machine–readable
(barcode) form (FDA 2017). Medical device companies operating under FDA guidelines will be
required to submit certain information about each device to the FDA's Global Unique Device
Identification Database (GUDID) (FDA 2014). In order to allow organizations ... Show more
content on Helpwriting.net ...
Problem Statement
Many companies have set forth action plans for UDI compliance, however, when they purchase the
Prisym ID solution, their personnel, from entry level through C–level have not had exposure or
training on the PRISYM 360 software application and do not have sufficient knowledge of the
application as required to perform their job. They may have understanding of the guideline
requirements, but they do not yet know how to translate it into creating the actual label for market
medical devices.
Problem Background and Causes
The FDA developed UDI in order to better track medical devices manufactured in the United States.
It was signed into law on Septebmer 27, 2007 as a part of the U.S. Food and Drug Administration
Amendments of 2007 (FDA, 2007). The law is recognized as a significant addition to overall FDA
authority, and as a result medical devices companies must implement the guidance to maintain
compliance with U.S. FDA, or be ordered to cease all operations. The organizations must prepare
and train personnel relative to the production labeling process in order to ensure product being sold
is in compliance. Because the employees are not yet trained on the proper usage is a concern to the
company if they are to meet the deadline for total compliance. The deadline as set forth by the FDA
is a phased in schedule between 2014–2020. The PRISYM 360 solution is UDI compliant, and the
instruction will allow the organizations' employees to

Genzyme 's Focus On Orphan Drugs
Genzyme 's Focus on Orphan Drugs In this fast paced world that we live in now it is all but
impossible to expect any one to wait for anything these days. We through the innovative
technological ideas and inventions you can make anything with in minutes what use to take hours.
Everyone wants to be a Chief Executive Officer, (CEO) of a major corporation making millions and
billions of dollars over night. No one wants to think through how can they take a company that is
barley able to keep it's door open and it's employees paid to the next level. No one wants to sit down
and make up an strategic plan to move a company to the level of excellence to make the millions
and billions. Now a days no one has the gumption to go to the board of directors and say that I want
to put the whole company at risk for a few years but when we come out we will be at the next level,
and oh yeah if we fail the company most likely will not exist no more. Technological innovations
has it's cost and most CEO's are not willing to take the risk that are needed in the research and
development stages to stay the course to reach greatness in the technology industry. We find very
few companies that are willing to say either we make it or we go under trying to get there. Henri
Termeer did just that with Genzyme Corporation that had only been in existence for two years. Mr.
Termeer was willing to put the whole company at risk for a strategic plan that most people said that
it would not work. Mr. Termeer not

Essay On Improvement In Medicine
An Improvement in Medicine
In the field of medicine, there has been a recent advancement of new oral anticoagulant drugs used
to treat many conditions such as atrial fibrillation, pulmonary embolism, and deep vein thrombosis.
Anticoagulant drugs have reduced the rate of strokes by 50% and are known to prevent clotting. In
1954, Warfarin was the only approved anticoagulant drug. However, recently the FDA has approved
three new oral anticoagulant drugs called Pradaxa, Xarelto, and Eliquis.
The first new oral anticoagulant (NOAC) to be approved was dabigatran. The Food and Drug
Administration and European Union approved it in 2008. The trade name for dabigatran is Pradaxa.
Ribaroxaban was the second new oral anticoagulant to be approved ... Show more content on
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"Thus, the dosage of warfarin must be carefully adjusted to keep the blood thinning effect in the
right range" (Unger). "Such problems have fostered research in the field of coagulation, and new
oral agents that selectively target coagulation factors have become available" (Roca 847–854). The
FDA conducted clinical trials to determine the efficiency of the three new oral anticoagulants
compared to warfarin. In their trails which included more than 50,000 patients from around the
globe, the FDA concluded that the three drugs were either equivalent to or more effective than
warfarin at preventing strokes. Some advantages of taking these new drugs are there is no need to
have periodic blood tests to monitor the dosage of medicine. "Of particular interest, the three new
drugs were substantially less likely than warfarin to cause a particular kind of bleeding leading to
stroke– a "hemorrhagic stroke," a stroke caused by bleeding into the brain, which is different from
the strokes caused by the clots that go to the brain in atrial fibrillation" (Unger). The effects after
someone stops taking Pradaxa, Xarelto, and Eliquis only last for a day or two, but the effects of
warfarin can last for many days after the medication is stopped.
In an interview with Dr. Charles Frye, he explained how he determines which NOAC is the best to
use for his patients. The

A Potent Intravenous, Reversible, Inhibitor, And The...
Cangrelor, a potent intravenous, reversible, platelet P2Y12 inhibitor, was recently approved by both
the United States (U.S.) Food and Drug Administration (FDA) and the European Medicines Agency
(EMA) as an adjunct for percutaneous coronary intervention (PCI). The approval was based on
Cangrelor versus Standard Therapy to Achieve Optimal Management of Platelet Inhibition
(CHAMPION) PHOENIX (1), a multi–center, double–dummy, double–blind trial, which
randomized 11,145 patients with stable angina, non–ST–segment elevation acute coronary
syndrome or ST–segment elevation myocardial infarction to receive cangrelor or clopidogrel at the
time of PCI.
CHAMPION PHOENIX (1) demonstrated that cangrelor significantly reduced the rate of ischemic
events without increasing severe bleeding. In the original analysis, bleeding was site–reported by the
blinded investigators according to pre–specified definitions and was not adjudicated. While the
EMA accepted this approach, during FDA review, the sponsor and the FDA independently re–
evaluated bleeding in a post hoc, non–blinded manner. This evaluation included potential bleeding
data not necessarily captured on the bleeding case report form (CRF) by the investigator, and
findings were categorized and interpreted according to jointly agreed criteria based on previously
published bleeding classifications. For example, there was a field in the CRF called "drop in
hemoglobin or hematocrit"; the review re–checked the laboratory dataset for

The Importance Of Post Clinical Trial Results In The...
Background Information
From 21 July 2014 it became compulsory to post clinical trial results in the European Clinical Trials
Database (EudraCT) which is managed by the European Medicines Agency (EMA) and it is
essential for clinical study information to be made more reachable and accessible. By saying
'Clinical Trial' the agencies are referring to any trials on new drugs that are in preparation for a
regulatory submission, drugs, devices or procedures on any medical interventions and any other
investigations that involves of participants for research purposes, for example psychology studies.
All of these clinical trials may generate numerous amounts of result or data. Traditionally only a few
results were published in journals and they ... Show more content on Helpwriting.net ...
This also avoids excessive research and expands the accessible evidence on an intervention.
Four sets of information are needed:
– Whether the trial has actually happened, which means it is necessary for the trial to be registered.
Information such as the study protocol, analysis plan and possible completion date of the trial could
be registered before the trial starts. This means the final result could be checked against the protocol
and would be easier to find out about any 'non–published' trials.
– Summary of the method and results – brief summary and result for every trial that was conducted.
– Clinical Study Reports (CSR) – to see whether there were any amendments to the protocol during
the course of the trial, which could mean that somebody has noticed something in the result and they
want to change the analysis in a way that is more flattering. Often information on adverse events is
very incompletely reported in journal articles but much more completed in CSR.
Clinical Study Report (CSR) is a lengthy and comprehensive document that gives information in
regards with the methods and results of a clinical trial. This document is submitted to regulatory by
a company who is looking for approval to market a 'novel drug'. It is a source that addresses efficacy
and safety.
– Individual Patient Data (IPD) – this can be defined as the raw data from a clinical trial that has
been treated to

The Pros And Cons Of Space Exploration
Space is the future of mankind; however; due to the words of a few, it may forever remain
unexplored. We have explored Earth, both land and sea almost entirely. Yet we still hunger for
adventure where else to look, but up at space and all it could contain?
There are people who say that outer space and the activities that are related to it are a waste of
resources and time for the government and private organisations. However, these people don't quite
realise what an effect the Space industry has not only on furthering our knowledge of the cosmos but
also in enabling us to learn more about Earth.
Space Exploration has allowed us to learn more about our world though satellites. Currently we
have 400 satellites in geo–stationary orbit – moving around earth at the same speed as the earth
rotates – with another 2,300 in varying orbits.
These satellites help to monitor and give warnings of dangerous weather, allowing for increased
time for evacuation and further preparation. Without such data we obtain from satellites hundreds of
thousands more would die in natural disasters such as hurricanes.
Communication is one of the cornerstones for modern development; without the communications
network we have the world would be much less advanced. It is therefore ironic that people use
platforms such as social media and the internet to spread their message about issues with space
exploration, as these platforms are only available to them because of the communications satellites
that space agencies such as NASA and ESA launch. A key developmental indicator is healthcare. It
also happens to be one of 3 factors used to determine a countries Human Development Index (HDI).
So, advances in the health sector that are due indirectly and directly to the space industry are
affecting many people in all walks of life. These advancements are widely varied: ear thermometers
which use the same radiation detection hardware as used when measuring temperature of stars. As
well as ventricular assist devices that are class–leading in both size and battery life therefore
allowing children and smaller adults the ability to live their life as normally as possible while they
wait on heart transplants. The rate of the technological advancements

19th Century American Imperialism
Industrial revolution motivated European powers like France, Germany, and Britain to expand their
imperial rule in the 19th century. They believed imperial expansion and colonial domination were
necessary for their survival of their states and societies. Modern imperialism allowed European
powers to profit from subject societies and influence their affairs without having to apply direct
political control. Modern colonialism further allowed European powers to control the subject's lands'
political, social, economic, and cultural structures. The major goals of European imperialism were
economic, political, military, and ideological reason. European nations need additional resources
and lands/trade routes, encouraging exploration that leads to national and personal glory,
technologic ... Show more content on Helpwriting.net ...
White colonizers believed that they had to impose their civilization on the distant lands because the
natives are uncivilized. "It is the greatest possible mistake to suppose that a European can acquire a
greater influence by adopting the mode of life of the natives. In effect, it is to lower himself to their
plane, instead of elevating them to his (Capt. F.D. Lugard, 3)." Imperialists viewed their beliefs as
the superior culture and if they were to adopt another culture rather than spread their, it would be a
downgrade for Europeans rather than help save the natives. Missionaries seek to introduce
Christianity to converts and other Europeans help civilized natives in political order and social
stability. Missionaries also have other benefits besides spreading Christianity. Missionaries help
make communication between imperialist and subject peoples easier, sometime provide information
to European officials on how to maintain control of oversea colonies, and their settlements also
served as a convenient meeting place for European overseas and as a distribution centers for
European manufactured

History Of The Hubble Telescope
It's been around for twenty years, it's made over 930,000 observations, it has taken around 570,000
images of celestial objects, it has helped us figure out how old our universe actually is, plus much
more. Do you know what NASA uses to find those things out? No? Yes? Well let me tell you, it's the
Hubble telescope. Now you may be asking what's the Hubble Telescope? What is a Hubble
telescope? Or you might just be thinking "oh I already knew what that was". If you know what I'm
talking about this shouldn't be too confusing for you, but if you don't know, well now you can
finally learn about what helps us discover many things in our solar system. The Hubble telescope
was not made by the actual person, in fact, it was named after him because ... Show more content on
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Some of its most important discoveries include the pictures it takes and sends to us. These images
have helped scientists estimate the age of the earth and the size of it. It is believed to be around 14
billion years old. It has detected black holes and if you don't know what black holes are they suck in
everything around them including light. The Hubble Telescope also has something to do with dark
energy and dark energy is a random force that has the ability to make the universe expand faster and
faster as time goes. Another, discovery is the telescope has discovered is the details of gamma rays
bursts and that is a powerful explosion of energy that happens when massive stars collapse. The
Hubble has also shown us how galaxies formed. It revealed extraordinary details about the process
by which sun–like stars and their lives as planetary nebulae. It may have helped is with identifying
quasars, it showed us pictures of a clashing galactic quintet, a densely packed star cluster, an eerie
"pillar of creation"., and famed butterfly nebula. It has shown us the birth of stars, and imagery of
the cosmos. Hubble's' millionth observation was a spectroscopic measurement, gas giants. Those
were just some of the many discoveries that the Hubble Telescope has

How Does Human Stasis Affect Human Space Travel
Research Question: How will human stasis affect human space travel? "Mars is there, waiting to be
reached." This is a quote by Buzz Aldrin, an astronaut on Apollo 11 along with Neil Armstrong, that
explains a global interest with the unknown and especially humans traveling to outer space, more
specifically: Mars. But the same question is asked over and over again by scientist all over the
world:"How do we get there"? This question has been mainly contemplated since 1969 and even
sooner for some groups. Most of the ideas brought to the national aerospace agencies are related to
building a better space–ship or stronger engines. But the achilles heel of all of these plans are the
same two things, cost and efficiency. Currently, sending four people to Mars is an estimated at six
billion U.S Dollars which many countries are not willing or able to spend. This estimate is also
conservative assuming everything is on time,budget, and in good working order. Human stasis in no
way is a mean of transportation, but instead a cost efficient way astronauts. Human stasis ... Show
more content on Helpwriting.net ...
A couple examples of unnecessary crew accommodation are food gallies, exercise equipment, and
entertainment. The reason why food gallies are dispensable is because of TPN. The astronauts no
longer need a food galley to go to cook their food on a stove and wash their dishes in the
dishwasher, or other appliances in a normal food galley. They also don't need the food galley as a
place to eat their food because all of their food is injected in their veins, skipping the usual process
of eating and digestion. They also do not need exercise equipment, that takes up lots of room in
modern spaceships. These are not needed because all of the humans are in stasis, unable to move.
Another example is entertainment. Entertainment is a major consideration when making a spaceship.
This is

Hubble Space Telescope: Business Analysis
GPS has helped transportation for businesses. With GPS technology, businesses can find shorter
routes for their cargo to travel17, saving fuel and time, but more importantly can track their cargo17
meaning businesses can review stock and plan accordingly for its arrival, and receive pre–warning
of any delays with their cargo which helps them manage inventory. GPS also prevents employee
fraud17as employers can tell exactly what hours their employees have driven which prevents
employees lying about the hours they worked and saves employers money. It is far easier to recover
cargo if it is lost or stolen en route17 with GPS which, once again, saves employers money. The
money spent on NASA, returns indirectly to the taxpayers, justifying its huge budget.
Air travel has been massively impacted by GPS. Flights are currently tracked by radar18 which
mostly works well over well–populated areas but can be problematic over remote, mountainous
areas where there are less radar stations or over the ocean. Planes must stick to established routes in
these areas and remain more ... Show more content on Helpwriting.net ...
This has helped us learn far more about the origins of our Universe and the formation of galaxies
from around a billion years after the creation of the Universe, where the galaxies appear to be very
shapeless and small, to today where they are larger and formed into spirals or discs. The Hubble
Space Telescope has helped pinpoint the age of the Universe to 13.7 billion years22 by studying 31
Cepheid variable stars22, whose fluctuating brightness can be used to calculate their distance thus
the expansion and therefore age of the Universe. Knowing the age of the Universe helps
astronomers and cosmologists model the Universe and its evolution over its lifetime accurately,
which is immensely valuable information to

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