TOPRA in India - Biosimilar Regulatory Landscape

TOPRA in India - Biosimilar Regulatory Landscape
TOPRA in India welcomes you to our webinar presentation:  Biosimilar Regulatory Landscape in Emerging Markets: Current Status, Challenges and Future Prospects

Date: Thursday 28 July 2022
Time: 10:30-11:30 BST (GMT +1)/11:30-12:30 CEST/15:00-16:00 India time

Regulatory principles governing biosimilars in emerging markets are still in the nascent stage in spite of a common regulatory framework proposed by WHO. There remains scope for streamlining of the regulatory standards in the emerging countries, leading to improved patient access to affordable medicines without compromising their quality, safety, or efficacy. 

The webinar focuses on the current status, challenges and future prospects of biosimilars in the emerging markets. 


Dr Hasumati Rahalkar is a strong regulatory professional with over 25 years of work experience in QA, QC, Regulatory Affairs and Product Development with core focus on handling regulatory affairs for US, EU and Emerging markets. She founded Metina PharmConsulting in 2012, focused on providing EU GMP & Global Regulatory services. Dr Rahalkar broadened her expertise in Biosimilars by completing her PhD in Regulatory Science with specific focus on Biosimilars at University of Hertfordshire in December 2021. She holds additional qualifications of Regulatory Affairs Certification (EU & US), Certification in Patent Drafting & Procedure, along with Post Graduate Diploma in Management & International Trade. She is a certified ISO lead auditor and is also awarded as Fellow, TOPRA (FTOPRA) for her contributions in the Regulatory field. 

Ramya Anantharaman is a regulatory and life science professional with hands-on experience of over 13 years in biopharmaceutical industry with core expertise in biosimilar development processes and regulatory requirements at different phases of product lifecycle.  Ramya’s technical expertise in biosimilars comes from her background of working in Research & Development  (Process Development) team for biosimilars combined with a rich regulatory experience spanning products both from microbial and mammalian expression systems from major biopharma firms in India. She has served as the CMC lead in her previous assignments, supporting for the regulatory filings with various Health Authorities. Besides biosimilars, her interests are also in Regulatory Affairs for Medical Devices. She is currently associated with Metina PharmConsulting Pvt. Ltd. as Senior Regulatory Consultant for Biologics since January 2021.


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


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28/07/2022 10:30 - 11:30
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