The American Course on Drug Development and Regulatory Sciences is an excellent and comprehensive 6 session course that “covers all aspects of global pharmaceutical medicine and medical product development sciences. This includes the discovery and development of new therapeutics, biopharmaceutical sciences, clinical pharmacology and trial methodology, good clinical practice and ethics, pharmacovigilance, and risk management, biostatistics, regulatory affairs, health economics, project and portfolio management, marketing, and new therapeutic approaches.”
I’ve had the pleasure of lecturing on quantitative principles for drug development decision-making for the last several years in Session 3 [Learning and Confirming Trials: Finding and Confirming the Right Dose], but this year I also had the opportunity to co-chair Session 3 with the fabulous Diane Jorkasky, and it was a great experience! As always, my postdoc supervisor and long time professional mentor Carl Peck stopped in to share his incredible insights on the criticality of understanding PKPD and the history of its adoption into the FDA drug review process.
I would recommend this course to any pharmaceutical professional who needs to understand the bigger picture and strategy behind drug development and regulatory review. It’s intense, but the connections that you make will benefit your career, and the learnings are incomparable!
My model is THIS BIG!