NDA Simulation Workshop: Pharmaceutical Development Decisions 2025

NDA Simulation Workshop: Pharmaceutical Development Decisions is organized by Pharmaceutical Education and Research Institute (PERI) and will be held from Apr 28 - 29, 2025 at Fairfax, Virginia, United States of America.

Description:
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”.