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RS.S3. – Regulatory Sciences: Innovation, Technology and Future Readiness
Session Chair(s)
Amita Bhave
Director of Regulatory Affairs, AstraZeneca India, India
This session will examine how cutting-edge scientific innovation and digital technology are reshaping the regulatory sciences landscape. With the rise of complex biologics, advanced therapy medicinal products (ATMPs), and AI-driven platforms, regulatory authorities and industry stakeholders must adapt to evolving paradigms of drug development and evaluation. The discussion will explore advanced regulatory tools and methodologies, such as model-informed drug development (MIDD), real-world evidence (RWE), digital biomarkers, and machine learning applications in regulatory review. In addition, the session will address the importance of regulatory agility, workforce upskilling, and cross-sector collaboration in preparing for the future. By fostering a shared vision between regulators, scientists, and innovators, the session aims to advance regulatory systems that are not only robust and science-driven, but also responsive to emerging global health needs.
Speaker(s)
Swapna Teja Gundala, MSC
Manager, Regulatory Affairs, Parexel International, India
Global Regulatory Harmonization for Gene Therapy Products
Kedar Suvarnapathaki
Director - Regulatory Affairs, Southeast Asia & India, Johnson & Johnson , India
Use of AI in Drug Development And Regulatory Affairs
Rishi Jain
Medical Director, Novartis, India
With the Additional Participation Of:
Dipankar Das
Director Biologics, US Pharmacopeia, India
With the Additional Participation Of: