DIA 2017 Annual Meeting

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