2nd Pharma Regulatory Asia in Beijing

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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/

Transcript of 2nd Pharma Regulatory Asia in Beijing

Page 1: 2nd Pharma Regulatory Asia in Beijing

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