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



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.

Search News & Events

  • Filter by category


Related news and events

EVENT | 20th Biosimilar Medicines Conference by MFE

During these two interactive days, actors of the healthcare community alongside world experts in biosimilar medicines will gather and debate the evolving biosimilar medicines landscape and emerging trends. Discussion will focus on sharing good practices and setting collective aims to achieve the depth, breadth and speed of the use of biosimilar medicines as a lever to untap their transformative value.

New opening! | Pamplona office

At Asphalion, we are thrilled to announce the opening of our new office in Pamplona! This strategic decision reflects our commitment to being closer to

For further information

If you are interested in our services, or wish to get in touch for a general enquiry, please contact us for more information.

Fill the form and we will contact you as soon as possible.

You can also follow us on:

Schedule a Free Meeting

Schedule here a free 30-minutes meeting with one of our consultants and tell us about your project, challenges or doubts. 

We will be happy to assist you!

Schedule a meeting