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Walter E. Washington Convention Center

2015 年 06 月 14 日 2:30 下午 - 2015 年 06 月 18 日 6:45 下午

801 Mount Vernon Place, NW, , Washington, DC 20001-3614 , USA

DIA 2015 51st Annual Meeting: Develop. Innovate. Advance.

Full conference and one-day registrants will have access to presentation PDFs through Friday, December 18, 2015 <A href="http://www.diaglobal.org/Flagship-Meetings/DIA-Annual-Meeting/Meeting-Program/ePac-Presentations-Access.aspx">Review Presentations </A>

Global Drug Development in China: Opportunities and Challenges for Innovation

Session Chair(s)

Joseph  Scheeren, PharmD

Joseph Scheeren, PharmD

Founder

Scheeren HealthCare LLC, United States

China has very dynamic regulatory policies in driving the development of innovative drugs. This forum will share experiences on regulatory opportunities and barriers that will impact development and availability of new drugs in China.

Learning Objective : Recognize the regulatory landscape in China; Discuss global drug development strategies in China including the utilization of multiregional clinical trials; Evaluate issues associated with drug lag for the approval of new medicines.

Speaker(s)

Shaoyu  Chen, JD

Understanding Regulatory Laws and Policies

Shaoyu Chen, JD

Covington & Burling LLP, China

Managing Director, China Food and Drug Practice; Partner

Daniel  Liu, PhD, MSc

Status and Requirements of Regulatory Registration for IND/NDA in China

Daniel Liu, PhD, MSc

Beijing Clinical Service Center, China

President & CSO

Patrick  Brady, PharmD

How to Design Global Regulatory Drug Development Strategies in China

Patrick Brady, PharmD

IQVIA, United States

Global Head, Therapeutic Innovation & Regulatory Science

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