FORUM INSTITUT COURSE | CMC Management in Regulatory Affairs

FORUM INSTITUT COURSE | CMC Management in Regulatory Affairs

📆 26-27 October, 2021

💻 Online course

ASPHALION expert André Mota, together with other two excellent lecturers will share their in-depth knowledge with you on CMC requirements for marketing authorisation.

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. Our experts will pass on their in-depth knowledge of challenges with essential quality data, CMC writing and global lifecycle management.

🔝 Use this link to register and benefit of a 10% discount on the course price:

https://www.forum-institut.de/seminar/2110273-cmc-management-in-regulatory-affairs/17/N/0/127210/fd7cc08

ASPHALION´S THIRD QUARTER HIGHLIGHTS 2021
ASPHALION REGTALK | RIMS SERIES