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:



Phar-East Day Two @ 13:45

Evidence Based Medicine (EBM) in Asia: Latest update

  • Learning from established framework to implement RWE-supported regulatory structures in Asia
  • Exploring the increasing importance of real world evidence in seeking drug approval
  • Preserving evidence quality with the increasing volume of clinical research
  • Developing, disseminating, and implementing better evidence for better healthcare

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