An introduction for those who may be interested in a career in clinical research, but need to understand the industry and their potential for a role in it.
Provides an overview of the later stages of drug development, explaining the phases of drug studies and explores in brief the key roles for those participating.
Find latest clinical trial jobs, clinical project manager jobs, SAS clinical programmer, clinical statistical programmer jobs in USA, New Jersey, New York and California
An introduction for those who may be interested in a career in clinical research, but need to understand the industry and their potential for a role in it.
Provides an overview of the later stages of drug development, explaining the phases of drug studies and explores in brief the key roles for those participating.
Find latest clinical trial jobs, clinical project manager jobs, SAS clinical programmer, clinical statistical programmer jobs in USA, New Jersey, New York and California
Guideline on patient safety and well being in clinical trialsTrialJoin
Patient safety is and should be the number one priority in clinical research. Human participants in a clinical trial are necessary in order to improve and develop new therapies for certain conditions and advance the understanding of how a condition can be treated. Such medical advancements wouldn’t be possible without human subjects as participants. However, even though we all know the importance of clinical trials in the advancement of medicine, most people still have some misconceptions regarding this topic.
The feeling of being treated as a ‘’guinea pig’’ and fear of potential risks and side effects are still common among patients who suffer from a certain condition. Such misinformation and misconceptions regarding clinical trials can unnecessarily prevent patients from finding a potential cure or relief, and can also decrease the number of enrolled patients in studies.
In order to clarify these misunderstandings, we’ve decided to tell you everything there is to know about patient safety in clinical trials. We hope that with this information we can help you to better understand patient safety in clinical trials so that you gain more insight and start considering clinical trials as valid options that can help you improve any condition.
The stages of Drug Discovery and Development processA M O L D E O R E
Drug development is the process of bringing a new pharmaceutical drug to the market once a lead compound has been identified through the process of drug discovery. It includes preclinical research on microorganisms and animals, filing for regulatory status, such as via the United States Food and Drug Administration for an investigational new drug to initiate clinical trials on humans, and may include the step of obtaining regulatory approval with a new drug application to market the drug
Good Regulators of Pharmaceuticals (GRP) 22 October 2014Ajaz Hussain
Sharing thoughts on what makes a Good Regulator of Pharmaceuticals with pharmacy students at the Universities of Minnesota and Iowa. A point of emphasis on "we all are regulators" is explained and three areas for learning - (a) Systems and Integrative Thinking, (b) Argumentation and (c) Behavioral Economics described.
I hope you, the viewers, will also find some value in reviewing these slides. If you are a student and have some questions please feel free to drop me a email (a2zpharmsci@msn.com).
Clinical Research is a most knowledge-intensive and interesting field in the pharmaceutical industry. There are more than 2, 50,000 positions unemployed in global Pharmaceutical industry.
Pakistan's Regulatory Approach: Can Quality of Drug be assured through Testin...Obaid Ali / Roohi B. Obaid
Disclaimer: It is purely personal point of view written in the best of professional knowledge and experience of dealing with affairs of regulatory sciences as Federal Regulator. In any way, it is not an obligation to agree by the organization or association to which we belong. The intent of writing is to sensitize culture of reading, learning, arguing and writing. Feedback: All critics, comments and questions will be welcome
Guideline on patient safety and well being in clinical trialsTrialJoin
Patient safety is and should be the number one priority in clinical research. Human participants in a clinical trial are necessary in order to improve and develop new therapies for certain conditions and advance the understanding of how a condition can be treated. Such medical advancements wouldn’t be possible without human subjects as participants. However, even though we all know the importance of clinical trials in the advancement of medicine, most people still have some misconceptions regarding this topic.
The feeling of being treated as a ‘’guinea pig’’ and fear of potential risks and side effects are still common among patients who suffer from a certain condition. Such misinformation and misconceptions regarding clinical trials can unnecessarily prevent patients from finding a potential cure or relief, and can also decrease the number of enrolled patients in studies.
In order to clarify these misunderstandings, we’ve decided to tell you everything there is to know about patient safety in clinical trials. We hope that with this information we can help you to better understand patient safety in clinical trials so that you gain more insight and start considering clinical trials as valid options that can help you improve any condition.
The stages of Drug Discovery and Development processA M O L D E O R E
Drug development is the process of bringing a new pharmaceutical drug to the market once a lead compound has been identified through the process of drug discovery. It includes preclinical research on microorganisms and animals, filing for regulatory status, such as via the United States Food and Drug Administration for an investigational new drug to initiate clinical trials on humans, and may include the step of obtaining regulatory approval with a new drug application to market the drug
Good Regulators of Pharmaceuticals (GRP) 22 October 2014Ajaz Hussain
Sharing thoughts on what makes a Good Regulator of Pharmaceuticals with pharmacy students at the Universities of Minnesota and Iowa. A point of emphasis on "we all are regulators" is explained and three areas for learning - (a) Systems and Integrative Thinking, (b) Argumentation and (c) Behavioral Economics described.
I hope you, the viewers, will also find some value in reviewing these slides. If you are a student and have some questions please feel free to drop me a email (a2zpharmsci@msn.com).
Clinical Research is a most knowledge-intensive and interesting field in the pharmaceutical industry. There are more than 2, 50,000 positions unemployed in global Pharmaceutical industry.
Pakistan's Regulatory Approach: Can Quality of Drug be assured through Testin...Obaid Ali / Roohi B. Obaid
Disclaimer: It is purely personal point of view written in the best of professional knowledge and experience of dealing with affairs of regulatory sciences as Federal Regulator. In any way, it is not an obligation to agree by the organization or association to which we belong. The intent of writing is to sensitize culture of reading, learning, arguing and writing. Feedback: All critics, comments and questions will be welcome
The Roman Empire A Historical Colossus.pdfkaushalkr1407
The Roman Empire, a vast and enduring power, stands as one of history's most remarkable civilizations, leaving an indelible imprint on the world. It emerged from the Roman Republic, transitioning into an imperial powerhouse under the leadership of Augustus Caesar in 27 BCE. This transformation marked the beginning of an era defined by unprecedented territorial expansion, architectural marvels, and profound cultural influence.
The empire's roots lie in the city of Rome, founded, according to legend, by Romulus in 753 BCE. Over centuries, Rome evolved from a small settlement to a formidable republic, characterized by a complex political system with elected officials and checks on power. However, internal strife, class conflicts, and military ambitions paved the way for the end of the Republic. Julius Caesar’s dictatorship and subsequent assassination in 44 BCE created a power vacuum, leading to a civil war. Octavian, later Augustus, emerged victorious, heralding the Roman Empire’s birth.
Under Augustus, the empire experienced the Pax Romana, a 200-year period of relative peace and stability. Augustus reformed the military, established efficient administrative systems, and initiated grand construction projects. The empire's borders expanded, encompassing territories from Britain to Egypt and from Spain to the Euphrates. Roman legions, renowned for their discipline and engineering prowess, secured and maintained these vast territories, building roads, fortifications, and cities that facilitated control and integration.
The Roman Empire’s society was hierarchical, with a rigid class system. At the top were the patricians, wealthy elites who held significant political power. Below them were the plebeians, free citizens with limited political influence, and the vast numbers of slaves who formed the backbone of the economy. The family unit was central, governed by the paterfamilias, the male head who held absolute authority.
Culturally, the Romans were eclectic, absorbing and adapting elements from the civilizations they encountered, particularly the Greeks. Roman art, literature, and philosophy reflected this synthesis, creating a rich cultural tapestry. Latin, the Roman language, became the lingua franca of the Western world, influencing numerous modern languages.
Roman architecture and engineering achievements were monumental. They perfected the arch, vault, and dome, constructing enduring structures like the Colosseum, Pantheon, and aqueducts. These engineering marvels not only showcased Roman ingenuity but also served practical purposes, from public entertainment to water supply.
Francesca Gottschalk - How can education support child empowerment.pptxEduSkills OECD
Francesca Gottschalk from the OECD’s Centre for Educational Research and Innovation presents at the Ask an Expert Webinar: How can education support child empowerment?
Honest Reviews of Tim Han LMA Course Program.pptxtimhan337
Personal development courses are widely available today, with each one promising life-changing outcomes. Tim Han’s Life Mastery Achievers (LMA) Course has drawn a lot of interest. In addition to offering my frank assessment of Success Insider’s LMA Course, this piece examines the course’s effects via a variety of Tim Han LMA course reviews and Success Insider comments.
June 3, 2024 Anti-Semitism Letter Sent to MIT President Kornbluth and MIT Cor...Levi Shapiro
Letter from the Congress of the United States regarding Anti-Semitism sent June 3rd to MIT President Sally Kornbluth, MIT Corp Chair, Mark Gorenberg
Dear Dr. Kornbluth and Mr. Gorenberg,
The US House of Representatives is deeply concerned by ongoing and pervasive acts of antisemitic
harassment and intimidation at the Massachusetts Institute of Technology (MIT). Failing to act decisively to ensure a safe learning environment for all students would be a grave dereliction of your responsibilities as President of MIT and Chair of the MIT Corporation.
This Congress will not stand idly by and allow an environment hostile to Jewish students to persist. The House believes that your institution is in violation of Title VI of the Civil Rights Act, and the inability or
unwillingness to rectify this violation through action requires accountability.
Postsecondary education is a unique opportunity for students to learn and have their ideas and beliefs challenged. However, universities receiving hundreds of millions of federal funds annually have denied
students that opportunity and have been hijacked to become venues for the promotion of terrorism, antisemitic harassment and intimidation, unlawful encampments, and in some cases, assaults and riots.
The House of Representatives will not countenance the use of federal funds to indoctrinate students into hateful, antisemitic, anti-American supporters of terrorism. Investigations into campus antisemitism by the Committee on Education and the Workforce and the Committee on Ways and Means have been expanded into a Congress-wide probe across all relevant jurisdictions to address this national crisis. The undersigned Committees will conduct oversight into the use of federal funds at MIT and its learning environment under authorities granted to each Committee.
• The Committee on Education and the Workforce has been investigating your institution since December 7, 2023. The Committee has broad jurisdiction over postsecondary education, including its compliance with Title VI of the Civil Rights Act, campus safety concerns over disruptions to the learning environment, and the awarding of federal student aid under the Higher Education Act.
• The Committee on Oversight and Accountability is investigating the sources of funding and other support flowing to groups espousing pro-Hamas propaganda and engaged in antisemitic harassment and intimidation of students. The Committee on Oversight and Accountability is the principal oversight committee of the US House of Representatives and has broad authority to investigate “any matter” at “any time” under House Rule X.
• The Committee on Ways and Means has been investigating several universities since November 15, 2023, when the Committee held a hearing entitled From Ivory Towers to Dark Corners: Investigating the Nexus Between Antisemitism, Tax-Exempt Universities, and Terror Financing. The Committee followed the hearing with letters to those institutions on January 10, 202
Synthetic Fiber Construction in lab .pptxPavel ( NSTU)
Synthetic fiber production is a fascinating and complex field that blends chemistry, engineering, and environmental science. By understanding these aspects, students can gain a comprehensive view of synthetic fiber production, its impact on society and the environment, and the potential for future innovations. Synthetic fibers play a crucial role in modern society, impacting various aspects of daily life, industry, and the environment. ynthetic fibers are integral to modern life, offering a range of benefits from cost-effectiveness and versatility to innovative applications and performance characteristics. While they pose environmental challenges, ongoing research and development aim to create more sustainable and eco-friendly alternatives. Understanding the importance of synthetic fibers helps in appreciating their role in the economy, industry, and daily life, while also emphasizing the need for sustainable practices and innovation.
Unit 8 - Information and Communication Technology (Paper I).pdfThiyagu K
This slides describes the basic concepts of ICT, basics of Email, Emerging Technology and Digital Initiatives in Education. This presentations aligns with the UGC Paper I syllabus.
Palestine last event orientationfvgnh .pptxRaedMohamed3
An EFL lesson about the current events in Palestine. It is intended to be for intermediate students who wish to increase their listening skills through a short lesson in power point.
4. Brigham Buhler
• Founder of Ways2Well, a
functional and
regenerative care clinic,
and of ReviveRX, a
pharmacy focusing on
health, wellness, and
restorative medicine
• Former medical
equipment and
pharmaceutical
representative for Eli Lilly
and Stryker for 15 years https://ways2well.com/company/meet-the-team
5. Why are ethics so important in BME?
Link to full episode:
https://open.spotify.com/episode/4mCXtp4ylKsOX5fHx6Qzd9?si=35165f38fd1647bf
Credit: Spotify
Play from 0:04:17 to 0:05:34
6. What kinds of ethics should
biomedical engineers be concerned
about? What stakeholders should
be considered when designing a
new product or treatment?
7. BMES code of ethics
https://www.bmes.org/bmes2023-policies
10. Satomi works in a research facility that provides statistical results for
the bioengineering firm TechCureCase. She is one of four interns
expected to go through hundreds of samples per day. At her first
week on the job, her supervisor informs her that all blood samples
are to be completely anonymous. No testing can be done if personal
information is revealed—meaning, the samples must be properly
disposed of if opened, or returned to the physicians if unopened to
be re-anonymized.
For the first five weeks, most of the new interns follow procedures
to check that samples were anonymized before testing occurred.
However, one of the interns, Max, failed to verify whether the
samples were anonymized. Halfway through the testing, Satomi
discovers the non-anonymized samples. She considers whether they
should tell their supervisor, but the other interns ask her not to
speak up so that they won’t get in trouble. One of the interns argues
that as long as they remove the information from the non-
anonymized samples, the batch would otherwise be fine. Max is
hesitant to go to their supervisor as it is his fault, but Satomi can see
that neither does he like the idea the other interns are suggesting.
What should Satomi do?
11. Milo recently got hired to work in the technical research
department of TechCureCase, a bioengineering firm that
develops new medical devices for more accurate diagnostic
testing of prostate cancer. Milo performs numerous tests to
determine the success rate of a new medical device the
company is testing. While nearly 98% of the known samples
have produced correct results, a few samples have proven to
have incongruous results.
During this longitudinal study, results from one of the negative
control samples surprises Milo as it changes from being
consistently negative to being consistently positive for early
stage prostate cancer. As no device has perfect sensitivity and
specificity, he initially believes the change is due to is a false
positive result or mislabeling during processing, and therefore
dismisses it. However, the next sample from the same
negative control patient again produces the same positive
result. Milo becomes certain there is either a technical issue
going on with the test, or the patient has actually developed
prostate cancer. When Milo talks about the issue with his boss,
Milo’s boss tells him to put the issue aside and focus on the
What should Milo do?
12. Willow’s company has been contracted to oversee data management for a
clinical trial. The trial is being conducted on a newly developed drug and
consists of applying the drug on the subject’s skin and monitoring the effects
the drug has. This trial is in the first phase of testing, meaning the goal of the
trial to determine if the drug is safe for human use.
The drug is applied topically and the rate at which the drug is absorbed into
the subject’s skin is monitored. After data had been collected from all the
subjects participating in the trial, Willow analyzed the data and found that there
was a wide range in the rate at which the drug was absorbed. All subjects
were given the same dosage amount, and it was expected that the drug would
be absorbed at a slow, constant rate. Some subjects showed this trend, while
others absorbed the drug at a high rate, meaning a high concentration of the
drug quickly entered their system. This was cause for concern because
absorbing the drug at a high rate could lead to serious health consequences
for the potential users of the drug.
Willow reported her findings to her client, the company which had developed
the drug. Her report outlined the wide range in rate at which the drug was
absorbed. The client was unsatisfied with the report and asked Willow to re-
analyze the data. However, this time they requested a report which contained
only the average rate at which the drug is absorbed. Willow knows that a
report which only presents the average rate of absorption will not show all the
safety concerns shown in the clinical trial data. However, her client ensures
her that her report will only be used to show investors that the drug has
progressed to clinical trials. Additionally, the company assures her that they
What should Willow do?
13. Suppose you are designing an
artificial heart…
• What ethical
considerations do you
need to make?
• What stakeholders are
involved?
• How would you know if
you are ethically
successful in your
product development?
Credit: https://pivotcenter.utah.edu/success-stories/the-jarvik-heart/
Robert Jarvik with the Jarvik-7, the first
successfully implanted human heart
14. What happened with the use of a shaver
device for surgeries?
Link to full episode:
https://open.spotify.com/episode/4mCXtp4ylKsOX5fHx6Qzd9?si=35165f38fd1647bf
Credit: Spotify
Play from 0:44:52 to 0:46:07
