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Session 0202: EXPERIENCE OF FORMAL CONSULTATION MEETINGS WITH CDE
Session Chair(s)
Chris Huang
CEO
Pharmacons Tech CO.,LTD, China
Following the policies to encourage innovative drug development, the number of CDE formal consultation meetings (communication meetings) increased significantly and the topics covered most areas of new drug development. In this session, speakers from domestic and multinational pharmaceutical companies will share their experience about formal consultation meetings with CDE on various stage of new drug development. A speaker from CDE will give an overview about communication meetings with sponsors and provide suggestions on how to manage the communication meetings with CDE better.
Speaker(s)
A Formal Two-Way Communication Meeting with CDE on IND of a Novel Anti-Cancer Drug Using Innovative Development Strategy
Hua MU, MD, PhD
WuXi AppTec, China
Senior Vice President ,Global Head of Product Development Service & Partnership
Effective CDE Consultation Meeting
Mary Sun
Pfizer Investment Co., Ltd, China
Regulatory Affairs Manager
New IND Process for the First in Class Drug CTA Approval at China CDE
Li CHEN
Hua Medicine (Shanghai) Ltd., China
CEO
Topic TBD
Representative Invited
CDE, Taiwan
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