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NDA Submission Strategy for New Chemical Entity (NCE) Products in Asia Pacific Countries to Reduce Drug Lag
Session Chair(s)
Shun Jin, MBA
Head, Regulatory Affairs, APMA
Sandoz Asia Pacific Pharmaceutical Pte., Ltd., Singapore
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.
Learning Objective : Describe the regulatory hurdles in the Asia Pacific region for a New Drug Application (NDA) submission; Explain the required information to work out proper strategy for new NCE products in the Asia Pacific region; Identify and predict key risk areas during the NDA registration process and implement proper mitigation plan to reduce the risks.
Speaker(s)
Regulatory Challenge for NDA Submissions in China
Ning Li, MD, PhD
Sanofi, China
Vice President, Head of Asia Regulatory and Medical Policy
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