Entry Level CMC - EU Edition MasterClass

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Chemistry, Manufacturing and Control (CMC) is key in the development and routine production of a medicinal product, and this course helps you .. Read more understand the basic requirements and how to reflect them in the CTD Module 3. The course covers the general requirements for small molecules and biologics.

Highlights

• Understand the Different Levels of Requirements in CMC during Development and Post-Approval Phase.
• Learn the basic CMC data requirements on drug substance and drug product on key topics
• Have an overview of the CTD dossier and a detailed review of the CTD Module 3
• Get an introduction to quality by design and ICH guideline Q12