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/

1. 14
25 – 28 March 20
g
The Westin Beijin
Chaoyang, China
East Asia
provals in China &
ug & Clinical Trial Ap
Accelerating Dr
What’s New in 2014?
Key Regulatory Update from the National
Institute for Food & Drug Control, China
Pediatric Investigational Plans (PIPs)
MORE Drug Regulations & Case Studies
Interactive & Open Discussion Session on
Quality by Design (QbD)
Electronic Regulatory Affairs
Learn from China Industry Best Practices
Discover Bridging Studies and Waiver
Opportunities
Pharmaceutical Marketing Regulations
Drug-Device Combination Products
2014 Regulatory Experts Include:
Prof. Ning Bao Ming
Annette Chiu
Stewart Geary
Deputy Director, Division of
Chemical Drugs/GMP
Inspector, National
Institute for Food and
Drug Control, Agency of
the CFDA, China
Regulatory & Medical Affairs
Director, GlaxoSmithKline,
Chairperson of the Regulatory
Affairs Committee,
Hong Kong Association
of the Pharmaceutical
Industry, Hong Kong
Vice President/Deputy Director, President,
Corporate Regulatory
BravoBio, China
Compliance & QA, Eisai Japan,
Director, The Japanese
Association of
Pharmaceutical Medication
(JAPhMed), Japan
Dr Wu Ke
May Wei
Global Regulatory Strategist,
Bayer Healthcare, China
PLUS! Informative Workshops on:
PRE-CONFERENCE WORKSHOPS • 25 MARCH 2014
POST-CONFERENCE WORKSHOPS • 28 MARCH 2014
A Preparing and Submitting Dossiers for Generic Drug Approval
B Gaining Global Approvals of Biosimilars
C Regulatory Strategies for Emerging Market Access
D Pediatric Drug Development
www.pharmaregulatoryasia.com
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Media Partners:
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Sciences
International Marketing Partner:
REGISTER NOW! Customer Service Hotline: +65 6508 2401 / +86 21 2326 3680