Ambrish Srivastava | Vice President- Medical Affairs, Clinical Research & Regulatory
Alkem Laboratories | India

Ambrish Srivastava, Vice President- Medical Affairs, Clinical Research & Regulatory, Alkem Laboratories

Working with Alkem Laboratories Ltd as Vice President – Medical Affairs, Clinical Research & Regulatory. After completion of MD in clinical pharmacology worked as Asst Professor in Lady Harding Medical College New Delhi for about 5 years. Worked in various Indian and Multinational pharmaceutical company since last 25 years in the area of Medical Affairs and Clinical Development including NCE, Generics and Biological drugs.
Participated in several National and International medical conferences as speaker on several diseases and drug therapy. He is a guest faculty in several Institutions and research centres in the area of clinical research and drug development.  
Life Member of Indian Medical Association (IMA), International Society of Pharmacovigilance, Research Society of Study in Diabetes in India (RSSDI). 
He has about 40 publications in Indian and International medical journals. He has been awarded Vishisht Chikitsa Medal in 1994 by Governor of Andhra Pradesh and Rashtriya Ratan Award in 2005 by Governor of Gujarat for community health.


Conference Day 1 @ 14:25

Understanding post-market data and ADR reporting for biosimilars in India

  •     Emphasising the importance of identifying immunogenicity for biosimilars
  •     Understanding impact of delayed ADR in biosimilars
  •     Utilizing Benefits-risk analysis to ensure safety

Conference Day 1 @ 14:50

Combined Q&A

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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