Speakers: Lan Huang (BeyondSpring); John Mao (Foresee Pharma); Vivian Mao (Abbott Vascular); Honggang Bi (Covance China); Guobin Wang (PPD China)
Organizers:
Date: 2017-09-21
Time: 14:00-16:30 Pacific Time
Registration fee: (USD):
Location: Online Webcast ONLY
Major Sponsor:
Vendor show vendors registered to date:
Registration: http://www.PBSS.org
Registration deadline:2017-09-21  (it will close sooner if the seating cap is reached)

About the Topic

Pharmaceutical and Medical Device companies today face a growing demand to expand their clinical trial programs into China in order to access the vast pool of patients. While there are clear benefits for conducting clinical trials in China, there are significant operational and regulatory challenges, which need to be addressed before overseas companies plan to conduct trials in China, either as a trial conducted solely in China or as part of a multinational trial involving Chinese patients. It is important that appropriate measures are put in place to satisfy the ever evolving Chinese clinical trial and approvability standards. In the meantime, the China FDA (CFA) has initiated a major effort to harmonize the regulatory and clinical practices with the developed world and has implemented a number of policies that have profound impact on the clinical and regulatory practices in China.

This workshop aims at discussing some of the regulatory and operational challenges when conducting clinical trials in China, in both, the Pharma and Medical device arena. The presenters who are industry leaders with deep experience with drug and device development in China will review some of the recent regulations for the Pharma and Device development in China and suggest ways to approach China’s FDA (CFDA). It will discuss challenges and solutions when conducting national or multinational device trials in China from the perspectives of a local Chinese CRO as well as global CROs with affiliates in China. The workshop will provide examples for early strategies to include China in the development as part of a global development plan. A case example will demonstrate how a global clinical Phase 3 trial would suffice for a US FDA and China FDA approval.

Lan Huang, PhD, BeyondSpring (Co-founder & CEO) 
John Mao, PhD, Foresee Pharma (SVP) 
Vivian Mao, MD, Abbott Vascular (Associate Director, Clinical Science) 
Honggang Bi, PhD, Covance China (Corporate Vice President and General Manager) 
Guobin Wang, PhD, PPD China (Director, Project Management)