Regulatory Science, Drug Development, and Public Health (PHW236A) will be offered online by the UC Berkeley School of Public Health in the Fall of 2023
To register, please visit the course catalog here.
Course Description
This interdisciplinary regulatory science course brings together participants working in regulatory agencies, public health, law, medicine, business, and policy to gain an understanding of the most prominent product regulation issues in the US and abroad. Innovation is needed to address the 21st century’s evolving regulatory landscape, in the context of new technologies, new understanding of diseases, and a sharpened lens on safety.
This new exciting area of science requires a new generation of trained regulatory experts and professionals in academic, government, industry, and public health sectors. Building regulatory capacity is important for the US as well as for the rest of the world. Aiming to address this demand for increased training, the course provides the information needed to understand the most important health practice and product regulation issues in the US and abroad from the perspective of current regulatory standards, their standards for evidence, and the role of innovation in regulatory science.
The course features networking opportunities with experts from regulatory agencies, biotech, and the pharmaceutical industry. These guest lecturers will discuss the ongoing need for interaction between government, academia, industry, and the public.
Instructor Information
Dr. Miller is a leading expert in the process of engaging stakeholders from both sides of the Atlantic to resolve significant health policy and public health issues. She has extensive experience in resolving regulatory issues in six disease areas, working closely with the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA) as partners in these projects.
Dr. Miller is the Director of the Forum for Collaborative Research (The Forum), a public and private partnership addressing cutting edge science and policy issues through a process of stakeholder engagement and deliberation. Dr. Miller is also a Professor (Adjunct) at the UC Berkeley School of Public Health. She developed and teaches a course on FDA and Drug Development based on case studies from the Forum's rich history in facilitating drug development.
Dr. Miller mentors interns and fellows pursuing regulatory, biotech, and translational medicine careers and she has published over 100 peer-reviewed publications on HIV treatment strategies and regulatory strategies for HIV and HCV.
Course Objectives
By the end of the course, participants will be expected to be able to:1. Demonstrate knowledge of the basic concepts of a regulatory path, regulatory science, innovation and ethical principles, and their application in areas of public health need from a global, regional and national perspective.
2. Identify, assess, and think critically about the basic tenets of regulation in public health settings, including infectious diseases and regulation of controlled substances.
3. Explain and critically evaluate the clinical research process and assess the underlying mandate for evidence, for benefit and for risk, at each stage of the process.
4. Understand the concept of level of evidence in the regulatory context, generally and for specific situations, such as products for children, or products to treat rare diseases.
5. Describe and apply regulatory science concepts and be able to think critically about the role for innovative regulatory science for specific health products, including small molecules, biologics, vaccines, medical devices and diagnostics, cellular tissue and genetic engineering.
Weeks at a Glance
Week 1: Introduction to Regulatory Science and Regulation
Week 2: Regulation and Public Health
Week 3: Drug Development Pathway
Week 4: Innovation in Trial Design and Data Use
Week 5: Surrogate Markers, Expedited Approval Mechanisms and Biomarker Qualification
Week 6: Assessing Benefit-Risk and Long-Term Safety
Week 7: Regulation of Biologics, Vaccines, and Medical Devices
Week 8: Final Group Presentations and Proctored Assessment
Student Testimonials
“Dr. Veronica Miller is a highly accomplished researcher and excellent teacher. She is one of the few out there who is able to see the 'big picture' and explain the nuances of the science-policy-practice interface. She also brings to the course unparalleled access to world-leading experts in public health, regulatory science and drug development. The course allowed me to think about things in a more precise and specific way. It also armed me with the knowledge I needed to get my first short correspondence in psychopharmacology published. I now have a second paper underway, and this wouldn't have been possible without the training I received in the course regarding the drug development process.”
- Laurence Wainwright Ph.D, Departmental Lecturer and Course Director, University of Oxford
"Thanks to Dr. Miller's course, I am no longer an outside observer to regulatory science and can see how our organization can have an effective and productive place within the drug development process."
- Rachel Gomel, Registry Director and Coordinator, PSC Partners Seeking a Cure
“Taking this course helped me to develop a clear understanding of the policies underlying current drug and biomarker regulation, its impact on clinical trial design, benefit-risk analysis, drug safety, and medical ethics.”
- Bita Fathipour, Microbial Biology BS, UC Berkeley
“The course has changed my perspective in such a way that I now view regulatory science as a broader scope of disciplines versus a single entity within the FDA.”
- Clarissa Martinez, Public Health MPH, UC Berkeley
“After taking this class, I feel that I have a much better sense of the intricacies of regulatory science, and all the things one must consider when evaluating a product.”
- Alexandra Tsitsiklis, Infec Diseases & Immunity PhD, UC Berkeley
“This course changed my perspective of thinking the regulatory process as a universal and straight-forward process for each drug. I think the course definitely changed my view about the complexity and importance of the regulatory process and I believe that my deeper understanding of regulatory science will be useful for my future bioengineering projects and biotech industry job.”
- Charlene Pan, Bioengineering UCSF Joint PhD
“This course highlighted the clinical and social needs behind these regulatory programs, and more importantly, discussed the benefit-risk consideration and risk mitigation measures involved in these programs in a depth greater than all classes that I have previously taken.”
- Raymond Dong, Translational Medicine MTM, UC Berkeley
