Postgraduate Course in Clinical Pharmacology, Drug Development, and Regulation
April 6, 7, 13, 14, 20 & 21, 2022 | 12-4pm ET
About this Course
49th Annual Postgraduate Course in Clinical Pharmacology, Drug Development, and Regulation
Tufts CSDD’s Postgraduate Course in Clinical Pharmacology, Drug Development, and Regulation will resume in 2022 as an interactive online course. This highly acclaimed program provides advanced instruction in practical and technical problem-solving in the areas of clinical pharmacology, drug development & clinical trial strategies, biopharmaceutical development, drug safety, and new drug regulation. During an exclusive Q&A session with a senior FDA official, participants will receive first-hand insights into FDA priorities and operations and will emerge with a better understanding of the regulatory process. For more information we have provided an agenda and a detailed program description from our most recent live course in 2020.
Clinical Pharmacology: Integrate the relevant pharmacology, pharmacokinetics, and statistics related to drug development and the nature of evidence required for proof of efficacy and safety.
Drug Development and Clinical Trials: Using a case-study approach, identify and solve practical, theoretical, and technical problems in human drug studies and analyze an experimental design for a new drug candidate.
Regulation: Evaluate the science, laws, and regulations pertaining to the development and review of new drug products in the U.S., Europe, Japan and other pharmaceutical markets.
*Course Dates in Purple*
Who Should Attend?
Physicians, pharmacists, marketing executives, clinical researchers, nurses, analysts, investors, and any professional working with or in the research-based drug industry
Professionals looking to begin work in the pharma or biotech sectors and seeking comprehensive and foundational industry knowledge and training
Individuals employed by regulatory agencies, academic institutions, outsourcing providers, consultancy firms, niche service providers, and other organizations involved in the research, development, and regulation of pharmaceutical products
Earn a Digital Course Completion Badge!
- Showcase the knowledge and skills you acquired from the program.
- Share your learning achievements with clients, employers, and colleagues on online platforms and social media networks like LinkedIn, Facebook and Twitter.
The Tufts CSDD Postgraduate Course is designed to provide students with a broad and comprehensive understanding of issues related to the development and regulation of drugs, biologics, vaccines, devices, and in vitro diagnostics. Lectures focus on basic drug development topics — such as translational medicine, clinical pharmacology, epidemiology, drug regulation, and adverse drug event reporting — as well as broader topics such as pharmacoeconomics, drug-device combinations, biosimilars, working with investigative sites, and drug marketing.
Kenneth Kaitin, PhD
Kenneth Kaitin is Professor and Senior Fellow at Tufts Center for the Study of Drug Development at Tufts University School of Medicine. He previously served as the group’s Director for 23 years. He is also an Advisory Professor at Shanghai Medical College at Fudan University, and he serves on the faculties of the European Center for Pharmaceutical Medicine at the University of Basel, and the American Course on Drug Development and Regulatory Science at the University of California, San Francisco. Dr. Kaitin is recognized internationally for his contributions in the fields of drug development policy and science. He consults, speaks, and writes on global trends in pharmaceutical development and regulation, and he has provided public testimony before the U.S. Congress. A former President of the Drug Information Association, Dr. Kaitin recently served as Editor-in-Chief of Expert Review of Clinical Pharmacology,and as a consultant to the U.S. Department of Defense on bioterror countermeasures. In 2011, he received the Dr. Louis M. Sherwood Award, granted by the Academy of Pharmaceutical Physicians and Investigators, in 2020 he was named Global Fellow in Medicines Development by the International Federation of Pharmaceutical Physicians, and in 2021 he received the Distinguished Achievement Award from the Sino-American Pharmaceutical Professionals Association (SAPA). Dr. Kaitin is a director on the boards of Curis, Inc. (NASDAQ: CRIS), Bio-Tree Systems, Inc., and QCDx LLC. He earned his BS from Cornell University and MS and PhD in pharmacology from the University of Rochester.
"Taking the Tufts course was a tremendously beneficial experience for me. I'm so grateful to have learned so much and met such wonderful colleagues. You created a fantastic roster of speakers and presentations." Past Participant
“Being new to the industry I appreciated that all the presentations provided excellent background information before examining each topic in more depth.” Past Participant
“The Regulation overview for U.S., E.U., Japan, and China were extremely useful. The presentation captured essential knowledge for those areas.” Past Participant
“The mock drug groups activity was very helpful because it brought together a handful of people from different backgrounds and professions. It encouraged team-building and communication — two things that are very much needed in the work field.” Past Participant
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