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McCormick Place

Jun 18, 2017 8:30 AM - Jun 22, 2017 12:45 PM

2301 South Martin Luther King Jr. Drive, Gate 4, Chicago, IL 60616

DIA 2017 Annual Meeting

Update from the CFDA

Session Chair(s)

Ling  Su, PhD

Ling Su, PhD

Research Fellow

Shenyang Pharmaceutical University, Yeehong Business School, China

In August 2015, China’s State Council issued an document entitled "The Opinions on Reforming Review and Approval Process for Drugs and Medical Devices", unveiling a long-awaited major regulatory reform plan, with five main goals: to improve regulatory review and approval quality, address the drug application backlog, upgrade quality of generic drugs, promote innovative drug research and development, and to enhance regulatory transparency. Since then, many reform measures have been implemented. In this session, members from various organizations in the China Food and Drug Administration (CFDA) in will discuss the major initiatives and progress, as well as the future directions of the regulatory reform in China.

Learning Objective : Identify and understand the latest CFDA’s activities and initiatives in regulatory reform as well their impacts on Chinese pharmaceutical regulation and enforcement; Recognize China’s evolving regulatory environment and future development.

Speaker(s)

Zhimin  Yang, MD

CDE Reform Measures

Zhimin Yang, MD

National Medical Products Administration (NMPA), China

Deputy Director, Center for Drug Evaluation

Rong  Zhang, MS

Strengthen Regulatory Enforcement on Clinical Trial Integrity and Data Quality

Rong Zhang, MS

China Food and Drug Administration (CFDA), China

Deputy Chief Technician, Center For Food and Drug Inspection

Duo  Dong

ADR Monitoring in China

Duo Dong

China Food and Drug Administration (CFDA), China

Deputy Division Director, National Center for ADA Monitoring

Xiaoling  Qin

Panelist

Xiaoling Qin

National Medical Products Administration, China

Director, Department of the Science & Technology & International Cooperation

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