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NDA Submission Strategy for New Chemical Entity (NCE) Products in Asia Pacific Countries to Reduce Drug Lag
Program Code:
407
Date:
Thursday, June 27, 2013
Time:
9:00 AM to 10:30 AM
EST
CHAIR
:
Shun Jin, MBA (SCHNON), Associate Director, Regulatory Affairs, Asia, Takeda Development Center, Singapore
SPEAKER
:
Ning Li,
MD,PhD (SPKNON), Vice President, GRA Head, Medical Policy, Asia,
Sanofi, China
Prior to joining Sanofi, Dr Li worked at USFDA for 12+ years as a regulatory reviewer and held positions with increasing responsibilities in the area of oncology and cardiovascular. He owned his doctorate degree from Uni of Iowa. He has published 30+ papers in clinical trial methodology.
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Description
This workshop will introduce the regulatory hurdles and strategy for a New Drug Application (NDA) submission in the Asia Pacific region. Presentations, together with interactive case studies, will help the audience understand how to reduce regulatory risk and drug lag with proper NDA strategy.
**Due to workshop format, seating will be limited and will be available on a first come, first served basis.
The Boston Convention and Exhibition Center (BCEC) has stringent regulations on maximum room capacities, and they are strictly enforced. Once all seats are occupied, DIA will be required to close the workshop, and no more participants will be admitted. Interested attendees are encouraged to arrive at workshops early in order to ensure seating. Please note, as a workshop with interactivity, this event will not be recorded.