TOPRA in India: Orphan Drug Regulations

TOPRA in India: Orphan Drug Regulations
TOPRA in India welcomes you to our webinar presentation - Navigating Orphan Drug Regulations: Promoting Innovation and Access for Rare Diseases.

Tuesday 23 April 2024
11:00-12:00 BST / 12:00-13:00 CEST / 15:30-16:30 IST

This webinar will cover a high-level understanding of Orphan Drugs, the difficulties in their development, comparative regulatory norms, global perspectives, significance of global regulations in facilitating the development of treatments for rare diseases and impacting the lives of affected individuals. This webinar will be helpful for the better understanding of Orphan Drug Regulations in various countries and various measures taken at global level for promoting. 
Our guest speaker will be Vipul Kumar Gupta, M.Pharma. Head of Regulatory Affairs. Takeda Biopharmaceuticals India Pvt. Ltd. 
Vipul has more than 16 years of experience in Regulatory and Corporate Affairs in various pharmaceutical companies. He has a Postgraduate qualification in Pharmacy (M. Pharma in Drug Regulatory Affairs) from the Faculty of Pharmaceutical Sciences at Maharishi Dayanand University, Rohtak. 

He has experience in policy advocacy, expedited regulatory approvals, regulatory strategies, operations and compliance for India and Emerging markets. He also has experience in regulatory filings and activities related to pharmaceuticals, biologicals, biosimilars, vaccines, medical devices, cosmetics, OTC products, novel foods and nutritional supplements. He has worked for companies such as Roche, Cipla, Glenmark, Baxter, Ranbaxy and Novartis. Currently he works for Takeda Biopharmaceuticals India Pvt. Ltd. as Head of Regulatory Affairs.  

Vipul has conducted many training sessions on various topics of Regulatory  Sciences. He also worked as one of the key member of organizing committee for developing and the executive course in drug development and regulatory ccience in India.  This course was nominated for a TOPRA award for Academic excellence. 

He has co-authored books on Drug Regulatory Affairs, capturing Drug Approval Process for Pharmaceuticals (IND, NDA, ANDA, SNDA) Medical Devices (IDE), Biologicals (BLA, Biosimilars), OTC, Orphan drug regulations  in US, EU, Canada, ASEAN and BRICS (Brazil, Russia, India, China and South Africa) Countries. 

  • TOPRA Members: Free  
  • Non-member: £45 (includes 2 months TOPRA membership)


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23/04/2024 11:00 - 12:00
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