FORUM INSTITUT COURSE | CMC Management in Regulatory Affairs

October 4, 2022

📆 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.

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