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Tuesday, June 28 • 10:30am - 11:30am
#220: Regulatory Changes in China and the Impact to Global Drug Development Planning

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Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: CME 1.00; IACET 1.00; RN 1.00

In August 2015, the Chinese Food and Drug Administration (CFDA) issued extensive changes to drug reviews and approvals. It has effectively redefined the definition of a new drug and the approval process for any new drug development as well as generics. While China is becoming the second largest pharmaceutical market, it would benefit all firms to carefully review and digest the impact of such a change to their global drug development planning; in turn, this allows them to take advantage of this change and properly adapt. This session will highlight the changes that have a direct impact on the clinical development strategy and share case studies with the audience to illustrate the best approach in handling these regulatory changes.

Learning Objectives

Recognize changes made by the Chinese Food and Drug Administration to drug reviews and approvals; Identify how to best leverage these changes for your new drug developments and generics.


Dan Zhang


Innovative Biopharmaceutical Drug Development in China: Trends and Transformations
Helena Zhang

Regulatory Changes in China
Feng Yi

Outline of Reforming IND/NDA Practice in China
Fudong An

avatar for Dan Zhang

Dan Zhang

Executive Chairman, Fountain Medical Development Ltd. (FMD)
Dr. Dan Zhang, the Executive Chairman of Fountain Medical Development, has more than 15 years of drug development experience. Previously, Dr. Zhang was the Head of Clinical Development and Global Safety Assessment at Sigma-Tau Research Inc., Vice President at the Quintiles Transnational... Read More →

avatar for Feng  Yi

Feng Yi

Former Assistant to the Director-General, CFDA; SVP, Medical and Reg Affairs, Fountain (Beijing) Medical Technology Development Co., Ltd.
avatar for Helena Zhang

Helena Zhang

Senior Director and Chief Medical Officer, Quintiles
Dr. Helena Zhang, MD. MBA is Senior Director and Chief Medical Officer for Quintiles in the Greater China region. In this role she provides medical and ethical leadership of projects conducted by Quintiles in China. She enhances the strategic partnerships with top hospitals, Key Opinion... Read More →

Tuesday June 28, 2016 10:30am - 11:30am EDT
109AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 08: Reg Affairs, Session