戻る Agenda
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)
Global Regulatory Harmonization for Gene Therapy Products
Swapna Gundala
Parexel International, India
Manager, Regulatory Affairs
Use of AI in Drug Development And Regulatory Affairs
Kedar Suvarnapathaki
Johnson & Johnson , India
Director - Regulatory Affairs, Southeast Asia & India
With the Additional Participation Of:
Rishi Jain
Novartis, India
Medical Director
With the Additional Participation Of:
Dipankar Das
US Pharmacopeia, India
Director Biologics