Sonika Shah | Head Regulatory Affairs
Amgen India | India

Sonika Shah, Head Regulatory Affairs, Amgen India

Sonika Shah is heading Regulatory Affairs function in Amgen India. Prior to joining Amgen, Sonika worked for various organizations including Sanofi, Bristol-Myers Squibb, UCB & Bayer is & has a robust experience of more than 13 years managing regulatory affairs for biological and new chemical entity and drug safety.

She has vast experience in developing and executing regulatory strategies for new drugs (biologicals and NCE), clinical development and life cycle management. In previous roles she has handled regulatory activities for Srilanka, Bangladesh, Nepal in addition to India. She played an instrumental role in setting up safety function in her past organization. She has the experience of working with different regulatory agencies like DCGI, DGFT, State FDA and CDL/CDTL. 

She is active member of Industry associations like OPPI (Organization of Pharmaceutical Producers of India)-Medical and Regulatory Working Group and regulatory council of ISCR (Indian Society for Clinical Research).

Appearances:



Conference Day 1 @ 15:30

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?

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