Falls Church, VA (PRWEB)
November 16, 2017
European Drug Assessment Policy for Biological Medicine:
Do You Know the Latest Developments—and Is Your Focus on CMC?
**An FDAnews Webinar**
Dec. 5, 2017 — 1:30 p.m. – 3:00 p.m. ET
If drugmakers could sell more biologics in Europe … would they?
Note: This is a trick question.
The answer isn’t necessarily ‘Who wouldn’t!’ It’s more like, ‘Yeah, as soon as this new European Drug Assessment Policy for Biological Medicines is figured out.’
And that’s where FDAnews come in.
FDAnews has invited EU biochemist and venture capitalist Keith Chidwick Ph.D. MBA to sort it all out in plain English.
Mark the calendar for Tuesday, Dec. 5, when Dr. Chidwick explains how to adjust operations to this key policy change and boost 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 including:
Eligibility and requirements to enter the centralized procedure
- Game-changing issues including comparability, the main CMC reason for refusal
- QbD as applied to biologics
- 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!
Biologics and chemical-based medicines are fundamentally different, nowhere as much as under new CMC requirements. Here’s a double-barreled opportunity to avoid costly mistakes while boosting sales too!
Meet the Presenter:
Keith Chidwick Ph.D. MBA, Technical VP-PAREXEL Consulting, has built a reputation in international regulation of biotech medicines and as a venture capitalist. Both a biochemistry researcher and business developer, Dr. Chidwick developed large-scale bio-manufacturing processes; was responsible for the technology transfer; and became closely involved in the funding of small biotech companies. Public service roles include that of UK expert at EDQM P4 BIO and participating in other EMA Guideline Drafting groups;…