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Drug & Cosmetic Rule Amendments: Changes in Regulations Governing Clinical Trials in India

Speakers

Bobby  George, PhD

Bobby George, PhD

Vice President & Group Head Regulatory Affairs, Reliance Life Sciences, India

Dr. Bobby George is Vice President & Group Head of Regulatory Affairs at Reliance Life Sciences, Mumbai. He holds Masters and Ph.D. in Pharmacology from Panjab University, Chandigarh. He has also completed Senior Management Program from IIM, Kozhikode. He has over 25 years of industrial experience. He has been with Reliance Life Sciences for over 2 decades now. At Reliance, he is responsible for all their regulatory services across Pharmaceuticals, Biosimilars, Blood products and Vaccines in both domestic and export markets. He has to his credit several publications including a book which he authored on healthcare laws and reforms called “The Act that Wasn’t”.

Arun D. Bhatt, MD

Arun D. Bhatt, MD

Consultant Clinical Research & Drug Development , Consultant, India

Dr Bhatt has extensive experience of over three decades in the Indian pharmaceutical industry in clinical research, drug development, and regulatory affairs. He has managed clinical development of novel molecular entities in diverse therapeutic areas in all clinical development phases. He has worked as a consultant in pharmaceutical medicine and clinical pharmacology. His past positions held include President, Clininvent Research Private Limited – a CRO, CEO of CMI (India) Private Limited and Medical Director of Novartis India Limited. He has been active in industry associations and was earlier the President of Indian Society for Clinical Research (ISCR). He is Editor-in-Chief of Perspectives in Clinical Research – the journal of ISCR.

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