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China Marketing Authorization Holder System Summit 2017

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Location

Jumeirah Himalayas Hotel Shanghai

1108 Meihua Road

Pudong District, Shanghai 201204

China

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China’s State Council announced on May 26, 2016, a detailed pilot plan for the Marketing Authorization Holder System (“MAH”) for drugs in 10 provinces in China. The “MAH” pilot plan is seen as a revolutionary process in the development of biopharmaceutical innovation in the country. The new system allows the license holders of a drug to sell in China using a contract manufacturer, instead of manufacturing the drug themselves. Under “MAH”, it is much easier for both international biotech and large pharmaceutical companies to capitalize on the Chinese market, the world’s second largest pharmaceutical market which continues to grow at double digit pace.

This invitation-only symposium is co-hosted by Shanghai Municipal Food and Drug Administration, Shanghai Jinshan District People’s Government, and STA Pharmaceutical, a WuXi AppTec company. The symposium will provide a forum for the CFDA, US FDA, pharma/biotech companies, and CMOs to discuss latest policy updates, share their experience and best-practices together.

14:00-14:15 Opening Speeches

Jinshan District Municipal People's Government

Shanghai Municipal Food and Drug Administration

14:15-16:15 Keynote Speeches:

China MAH System Exploration and Future Development - China Food and Drug Administration

Regulating Pharmaceuticals in a Global Environment: US FDA Perspective - Dr. Leigh Verbois, Ph.D., FDA Country Director, China -

Progress of MAH Pilot Program in Shanghai - Shanghai Municipal Food and Drug Administration

The Investment Environment of Jinshan District for Biomedicine Industry - Jinshan District Municipal People's Government -

16:15-16:30 Tea Break

16:30-17:30 Panel Discusstion

Chaired by: Dr. Steve Yang, Chief Business Officer and Chief Strategy Officer, WuXi AppTec

Ms. Hua Zhang, Associate Director, Shanghai Center for Drug Evaluation and Inspection

Dr. Jonathan Liu, China Head, PDMS, Johnson & Johnson

Dr. Zhihong Ge, Associate Vice President, Global Development Quality, Merck

Dr. Li Chen, CEO, Hua Medicine

Dr. Zhenping Wu, Senior Vice President, Pharmaceutical Sciences, Hutchinson MediPharma

Dr. Minzhang Chen, CEO, STA Pharmaceutical, a WuXi AppTec company

17:30-18:30 Networking Reception

Date and Time

Location

Jumeirah Himalayas Hotel Shanghai

1108 Meihua Road

Pudong District, Shanghai 201204

China

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