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Session 7A: Industry-Regulator Interactions - Global Clinical Review Practices
Session Chair(s)
Arun Mishra, MSc
Director and Head, Regulatory Affairs
Abbott India Ltd., India
This session will focus on examples of robust industry regulator interactions during the regulatory review process in key developing and developed countries across the globe. Speakers will demonstrate how collaboration makes for greater effectiveness and efficiency of the review process and aids improved decision-making.
Speaker(s)
Elements of an Effective and Efficient Review Process – Examples from Key Emerging Markets, EU, US and Switzerland
Chet Elias
Amgen, United States
Director, GRAAS JAPAC
Engaging Regulatory Authorities During Complex Drug Development – Scientific Advice Process in Emerging Markets
Arun Mishra, MSc
Abbott India Ltd., India
Director and Head, Regulatory Affairs
Sound Clinical Reviews/Mind Over Matter - Any Role for the Heart
Aamir Shaikh
Assansa, India
Founder
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