FDAnews Announces — European Drug Assessment Policy for Biological Medicine Webinar, Dec. 5, 2017

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Some biologics makers may view the EU’s new CMC policy as a hurdle. Here’s why it’s also a golden sales opportunity.

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
http://www.fdanews.com/europeandrugassessment                

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; and serving on the control board of the National Institute of Biological Standards and Control (NIBSC).

Who Will Benefit:
This presentation is aimed at the drug development and assessment process in Rx and biologics firms. From lab scientists to quality control/GMP, from regulatory affairs to sales/marketing to the executive suite, everyone with an interest in these processes is a target attendee.

Webinar Details:
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
http://www.fdanews.com/europeandrugassessment                    

Tuition:
$287 per site

Easy Ways to Register:
Online:     http://www.fdanews.com/europeandrugassessment                                                                                    
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
FDANEWS
+1 (703) 538-7665
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