University of California, Berkeley, School of Public Health Course Offering. This interdisciplinary course reviews the history, authorizing statute and regulatory authority of US FDA and the influence and impact of FDA on science and health policy. Using the Forum for Collaborative HIV Research’s experience in HIV/AIDS and HCV, we demonstrate the interdisciplinary nature of the agency’s mandate (basic sciences, statistics, clinical medicine, ethics, toxicology, pharmacology, policy, law, political science, economic, foreign policy) and its impact on public health policy. Real-time examples such as maintaining quality of generic drug products distributed through PEPFAR, development of regulatory policy on the use of next generation sequencing platforms in the HIV and HCV space, and HIV cure research serve as case studies to illustrate both the ability of public entities to affect FDA policy and FDA’s impact on society. Biotech and pharmaceutical industry experts will participate as guest lecturers to illustrate the ongoing need for interaction between the agency, academia, industry and public health community. The course will be of interest to students in public health, law, medicine, business or policy interested in biotech and the pharmaceutical industry.
Instructors: Veronica Miller, PhD; Jur Strobos, MD, JD, FACEP
Course Evaluations:
"This is a great course for anyone who is interested in drug development and not only HIV, HCV. Veronica and Jur are wonderful professors, who are approachable and extremely willing to help and connect their students to people in industry." – David Elfant, UC Berkeley MBA Candidate
"This was an awesome course with a whole lot of new things to learn and discuss. Everyone interested in the areas covering drug development, toxicity studies, medical devices, etc. must participate in this fruitful and fun experience."
"Not only does it fully comply with my expectations but the class also allows me to compare the pharmaceutical sector in France and all I have been learning during my pharmacy studies with the situation in the USA. It is, in my opinion, an interesting way to learn, draw conclusions about the medicines regulation and to forge links between countries. The course represents also a great opportunity to meet people and interact with them. I have really enjoyed the experience, thank you!" – Sarah Palazeulos, UC Berkeley Visiting Student Researcher
"The course was very useful for me. As a Chemistry major starting out a career in biotech, the class was indispensable."
"It was such a wonderful course, and please do it again...and again!" – Aung Chein, UCSF Co-investigator and Postdoctoral Fellow
"One of the best classes I have taken. So informative and interesting. Particularly unique was hearing from industry experts at the front lines of drug development and health policy. It's definitely a one-of-a-kind course."
"Thank you for a very wonderful and informative course. It was really nice to learn about FDA regulations and history behind the drug approval for current drugs in the market and the patient advocacy."
"This interdisciplinary class provides a complete and detailed overview of the drug development process, and the challenging related issues. It covers a lot of interesting and useful topics. I am very happy and thankful for having been able to take this class, and thus benefit from the knowledge and experience of our professors, who are both not only experts in that field, but also excellent teachers. Our professors successfully stimulated thought and class discussions, which made this class particularly enthralling. They also organized several networking events, and a great panel discussion. It was highly interesting and enjoyable to study, discuss, and exchange ideas with people having different backgrounds. The knowledge I gained in this class will be very helpful for my legal career." – Kathia Pauchard, UC Berkeley Visiting Law Scholar
"As a postdoc scholar working in the field of cancer biology at UCSF, I would like to explore job opportunities in regulatory affairs in pharmaceutical/biotech companies later on. It would be very helpful for my career development towards my goal if there is any training program at UC Berkeley on FDA regulatory affairs." – Meng Chen, UCSF Postdoctoral Fellow
"A fantastic introduction to drug development and FDA regulation taught by two incredibly competent and talented lecturers!"
"Excellent organization, knowledge transfer, and communication." – Ling Zhang, UCSF Postdoctoral Fellow