📆 13-14 October, 2022 💻 Online course
ASPHALION expert André Mota, together with other two excellent lecturers will share their in-depth knowledge with you on CMC Management in Regulatory Affairs.
The online training course organized by FORUM INSTITUT will cover the following topics:
- Regulatory requirements in the EU and the ICH region
- Essential quality data for marketing authorisation
- CMC documentation: Module 3, ASMF, CEP and Quality Overall Summary
- Management of post-approval changes
- Classification of quality related variations
AIMS AND OBJECTIVES:
This online training will provide you with practical information on CMC requirements for marketing authorisation in the ICH region. The experts will pass on their in-depth knowledge of challenges with essential quality data, CMC writing and global lifecycle management.
