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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)
Yi Feng
SVP, Medical and Reg Affairs, Fountain Medical Development Ltd., China
Role of Clinical Review in SFDA/CDE: Yesterday, Today and Tomorrow
Krishna Prasad, DrMed, MD, MRCP, FRCP
Deputy Director, Innovative Medicines, HQA/Licensing, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
How to Win the Lottery on the Review Process
Aamir Shaikh
Founder, Assansa, India
Sound Clinical Reviews: Mind over Matter - Any Role for the Heart?
Ning Li, MD, PHD
Vice President, Head of Asia Regulatory and Medical Policy, Sanofi, China
Panelist
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