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Clinical Reviews
Session Chair(s)
Mark Goldberger, MD, MPH
Mark Goldberger MD MPH LLC, United States
Participants will hear from regulators and from industry about the critical elements of a product review. How do regulators "get the most bang for their buck and what are they most likely to be looking for. There will also be a discussion of the steps that a sponsor can take to facilitate the review process.
Speaker(s)
Role of Clinical Review in SFDA/CDE: Yesterday, Today and Tomorrow
Yi Feng
Fountain Medical Development Ltd., China
SVP, Medical and Reg Affairs
How to Win the Lottery on the Review Process
Krishna Prasad, DrMed, MD, MRCP, FRCP
Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Deputy Director, Innovative Medicines, HQA/Licensing
Sound Clinical Reviews: Mind over Matter - Any Role for the Heart?
Aamir Shaikh
Assansa, India
Founder
Panelist
Ning Li, MD, PhD
Sanofi, China
Vice President, Head of Asia Regulatory and Medical Policy
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