The NDA Simulation Workshop: Pharmaceutical Development Decisions, originally scheduled for August 4 – 5, 2025, has been cancelled.

In this highly interactive course, participants gain an understanding of the overall pharmaceutical development and regulatory processes by forming a “project team” working together to get a product approved with the required label and within the projected timeline and budget. The initial part of the course covers pharmaceutical development strategy, global regulatory considerations, toxicology, pharmacology, non-clinical safety and chemistry, manufacturing, and control (CMC), leading to the development of a simulated IND. Subsequently, clinical development sessions are added, to provide the groundwork for the development of a simulated NDA. Both the IND and NDA are submitted to, reviewed by, and commented on, by the course instructors, serving as “FDA reviewers”.

Course Prices:
Individual Course Registration: $1,925.00 USD
Early Individual Course Registration: $1,725.00 USD

Please allow up to 24 hours to receive your official course registration confirmation.