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Monday, June 19 • 11:00am - 12:30pm
#115: Update from the CFDA

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Component Type: Session
Level: Intermediate
CE: CME 1.50; IACET 1.50; RN 1.50

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 Objectives

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.

Chair

Ling Su, PhD

Speaker

CDE Reform Measures
Zhimin Yang, MD

Strengthen Regulatory Enforcement on Clinical Trial Integrity and Data Quality
Rong Zhang, MS

ADR Monitoring in China
Duo Dong

Panelist
Xiaoling Qin



Speakers
DD

Duo Dong

Deputy Division Director, National Center for ADA Monitoring, China Food and Drug Administration (CFDA)
DD

Duo Dong

Deputy Division Director, National Center for ADA Monitoring, China Food and Drug Administration (CFDA)
XQ

Xiaoling Qin

Deputy Director General, Department of International Cooperation, China Food and Drug Adminsitration (CFDA)
ZY

Zhimin Yang

Division Director, Center for Drug Evaluation, China Food and Drug Administration (CFDA)
RZ

Rong Zhang

Deputy Chief Technician, Center For Food and Drug Inspection, China Food and Drug Administration (CFDA)
Zhang Rong, Deputy Chief Technician, have been working for Center for Food and Drug Inspection for 20 years in the field of Medcial Devices inspection, GCP inspection.


Monday June 19, 2017 11:00am - 12:30pm
S403ab McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
  • format json
  • Featured Topics Clinical Operations,Global Regulatory
  • Credit Type CME, IACET, RN
  • Tags Session