You are registering for the NDA Simulation Workshop program, which will be presented online November 7 -9, 2022. This is the new, rescheduled date from the initial course date in September 2022.. 

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 label as part of the NDA submission process. Both the IND and product label are submitted to, reviewed by, and commented on, by the course instructors, serving as “FDA reviewers”.

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