Tufts CSDD’s 49th Annual Postgraduate Course in Clinical Pharmacology, Drug Development, and Regulation

Tufts CSDD’s five-day Postgraduate Course in Clinical Pharmacology, Drug Development, and Regulation will resume in 2022 as a live or hybrid event.  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.

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 

Course Goals:

The Tufts CSDD Post-Graduate 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.

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.

Feedback from past participants:

"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."
“Being new to the industry I appreciated that all the presentations provided excellent background information before examining each topic in more depth.”
“The Regulation overview for U.S., E.U., Japan, and China were extremely useful. The presentation captured essential knowledge for those areas.”
“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.”

For more information:
Please contact Sundé W. Daniels at sunde.daniels@tufts.edu