Shubhadeep Sinha | Head Global and Vice-President, Clinical Development and Medical Affairs (CD and MA)
Hetero Drugs Ltd | India

Shubhadeep Sinha, Head Global and Vice-President, Clinical Development and Medical Affairs (CD and MA), Hetero Drugs Ltd

Dr Shubhadeep Sinha is a senior pharmaceutical physician with over 17 years of experience in Global Clinical Development, Pharmacovigilance, Medical Affairs in Pharmaceuticals &  CROs. He is Currently Vice-President and Head- global clinical, medical and pharmacovigilance operations at Hetero group of pharmaceuticals. He is highly experienced in setting up, expanding and operating teams in clinical development, global pharmacovigilance, medical affairs in Pharmaceuticals including Dr. Reddy’s, Hetero, Glenmark, Organon & CROs including Vimta Labs, Alquest LLC. He has also managed end to end clinical development of multiple biosimilars including Darbepoetin, Rituximab, Bevacizumab, Adalimumab and currently ongoing Trastuzumab and a few others at Hetero including domestic and international development & registration.


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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