European Drug Assessment Policy for Biological Medicine: Do You Know the Latest Developments—and Is Your Focus on CMC?
Tuesday, December 5, 1:30 pm - 3:00 pm
Biologics and chemical-based medicines are fundamentally different, nowhere so much as under CMC policy changes set forth recently by the EU. But savvy biologics makers are already seeing a double-barreled opportunity in the EU’s action — avoiding costly compliance errors while boosting sales in the bargain.
The impact of the new CMC policy is enormous, affecting drug and biologics makers in dozens of drug development and assessment areas. Dr. Chidwick guides you through the fine print, including key issues such as:
Eligibility and requirements to enter the centralized procedure
Game-changing issues including comparability, the main CMC reason for refusal
QbD as applied to biologics (this one could be your strike-it-rich bonanza!)
Strategic validation — understanding the big decisions that begin in early product development
Best practices for biosimilars in the EU, given that the CHMP (Committee for Medicinal Products for Human Use) is now experienced in biosimilars and certain common themes have been identified
And much more!
This new EU policy is a game-changer for drug and biologics makers. You fail to comply at your peril ... but proper compliance and understanding can fatten the bottom line. Who wouldn’t want that?
Keith Chidwick - Technical VP, PAREXEL Consulting