Dr. Bobby George is Vice President & Head of Regulatory Affairs at Reliance Life Sciences, Mumbai. He holds a Masters and Ph.D. in Pharmacology from Panjab University, Chandigarh and has over 19 years of industrial experience. At Reliance, he has been for over 14 years and is responsible for regulatory services in both their domestic and export markets. He has been part of the team involved in getting 14 of their biosimilars commercialized in India with several others including mAbs, in various phases of clinical & preclinical development. Dr. Bobby has to his credit, 31 publications in both national and international peer reviewed journals. He has authored 3 book chapters and is on the editorial board as a reviewer for 2 peer reviewed journals.
Conference Day 1 @ 15:00
How can regulators and pharma work closer together to establish a robust regulation framework?
wing India’s efforts to strengthen its regulatory landscape, there have been several updates and revisions of requirements and regulations. This constant changing in regulations has posed many challenges to pharma companies. This panel discussion explores how pharma and regulators can collaborate to establish a robust yet understandable regulatory framework.
- What are some of the recent updates in regulations?
- How effective are the subject expert committee, therapeutic committee and apex committee in actioning change in policies?
- How can regulators and pharma work more closely together?
Shubhadeep Sinha, Head Global and Vice-President, Clinical Development and Medical Affairs (CD and MA), Hetero Drugs Ltd
Sonika Shah, Head Regulatory Affairs, Amgen India
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