Postgraduate Course in Clinical Pharmacology, Drug Development, and Regulation

Online Course

February 1,  2,  8,  9,  15 & 16, 2023 | 12-4pm ET

About this Course

50th 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 2023 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 online course in 2022.

Educational Objectives

  • 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.

February 2023

*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 & Certificate!

  • 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.

Course Goals:

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.

Course Moderator 

Kenneth Kaitin, PhD

Professor of Medicine and Senior Fellow

Kenneth Kaitin is Professor of Medicine at Tufts University School of Medicine and Senior Fellow at Tufts Center for the Study of Drug Development, where he previously served as Director for 23 years. He is also an Advisory Professor at Shanghai Medical College at Fudan University in China, and serves on the faculties of the European Center for Pharmaceutical Medicine at the University of Basel, the American Course on Drug Development and Regulatory Science at the University of California, San Francisco, and the IFAPP Academy-Kings College London Medical Affairs in Medicines Development Certification Program. Dr. Kaitin is internationally recognized for his contributions to the field of drug development policy and science. He consults, speaks, and writes on global trends in pharmaceutical development, and has provided public testimony before the U.S. Congress. A former President of the Drug Information Association, Dr. Kaitin 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 in 2020; 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

Early Bird Rate

(Ends 11/1/22) 


Center Supporter Rate

(No end date)



(No end date)


*To inquire about group rates, please email


Have any questions? Enter your information below to get in touch with our enrollment team.