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FORUM INSTITUT COURSE | CMC Management in Regulatory Affairs

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.

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.
July 26, 2023
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📆 24-25 October, 2023 💻 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

For further information, you can also contact us at: [email protected]

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