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With the growth and development of the biopharma industry and increasing changing legislations on areas like biosimilars, pediatric drug development and generic drugs in China and East Asia, now is the time for you to bring along your regulatory affairs teams to keep abreast of evolving regulatory environments and requirements at IBC’s 2nd Pharmaceutical Regulatory Summit in China. http://www.pharmaregulatoryasia.com/
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REGISTER NOW! Customer Service Hotline: +65 6508 2401 / +86 21 2326 3680
International Marketing Partner:
www.pharmaregulatoryasia.com
Produced by:
LifeSciences
Accelerating Drug & Clinical Trial Approvals in China & East Asia
Media Partners:
What’s New in 2014?
25 – 28 March 2014The Westin Beijing
Chaoyang, China
Supporting Organisation:
2014 Regulatory Experts Include:
Prof. Ning Bao MingDeputy Director, Division ofChemical Drugs/GMPInspector, National
Institute for Food and
Drug Control, Agency ofthe CFDA, China
May WeiGlobal Regulatory Strategist,Bayer Healthcare, China
Dr Wu KePresident,BravoBio, China
Stewart GearyVice President/Deputy Director,Corporate RegulatoryCompliance & QA, Eisai Japan,Director, The Japanese
Association of
Pharmaceutical Medication
(JAPhMed), Japan
Annette ChiuRegulatory & Medical AffairsDirector, GlaxoSmithKline,Chairperson of the RegulatoryAffairs Committee,Hong Kong Association
of the Pharmaceutical
Industry, Hong Kong
Key Regulatory Update from the NationalInstitute for Food & Drug Control, China
MORE Drug Regulations & Case Studies
Electronic Regulatory Affairs
Learn from China Industry Best Practices
Pharmaceutical Marketing Regulations
Pediatric Investigational Plans (PIPs)
Interactive & Open Discussion Session onQuality by Design (QbD)
Discover Bridging Studies and WaiverOpportunities
Drug-Device Combination Products
PLUS! Informative Workshops on:
A
B
C
D
PRE-CONFERENCE WORKSHOPS • 25 MARCH 2014
Preparing and Submitting Dossiers for Generic Drug Approval
Gaining Global Approvals of Biosimilars
POST-CONFERENCE WORKSHOPS • 28 MARCH 2014
Regulatory Strategies for Emerging Market Access
Pediatric Drug Development