$20 – $35

China Business Opportunities & Regulations in Medical/Pharma/Diagnostics

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Barnes & Thornburg LLP

11 South Meridian Street

Indianapolis, IN 46204

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SPEAKERS:

  • Mr. Yongheng Chang - Executive Chairman of the China International Medical Device Regulatory Forum (CIMDR) of China Center for Food and Drug International Exchange (CCFDIE) of the National Medical Product Administration (NMPA) of China. Former Deputy Director General of CCFDIE of CFDA (China Food and Drug Administration).

  • Ms. Celia Feng – Co-Founder & Sr. Vice President of Pharos-PharmaStudies-China, a full service CRO for pharmaceutical, medical device and IVD clinical trials (phase I-IV) and CFDA registrations since 2008; Former regulatory and government affairs director and senior management positions for Lilly, Novartis, Roche, MSD, Bayer since 1988.

  • Ms. Min Yue – MinYue Consulting, focusing on US-China pharmaceutical, medical device and IVD businesses; Former Sr. Manager at Beckman Coulter Global and China Regulatory Affairs; Former Manager and Project Lead positions at Eli Lilly and PAREXEL.

TOPICS:

  • China medical products market, patients needs and opportunities

  • China government agencies for medical product importation management – NMPA (formerly CFDA) new org structure, regulations and policies

  • China clinical research, registrations and post marketing trials (phase I-IV) regulations, requirements, and processes

  • China access for US based manufacturers – strategies & processes

  • Q&A with Panelists


AGENDA:

1:30pm Registration and Networking
2:00pm Program Begins
4:00pm Cocktail and Hors D'oeuvres with Speakers

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Barnes & Thornburg LLP

11 South Meridian Street

Indianapolis, IN 46204

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