Agenda - Agenda for Day Three - Wednesday 30 September, 2026 | Global Pharmaceutical Regulatory Affairs Summit

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General Session

13:00 - 13:45

The New Era of Regulatory Collaboration - Building Successful Partnerships Across Health Authorities and Industry

Understand the drivers behind increased collaboration among health authorities and between industry and regulators
Explore real-world examples including FDA-EMA joint initiatives and the PRISM project
Identify opportunities for your organiation to participate in or initiate collaborative efforts

Zainab Aziz - Associate Director RA Policy and Strategic Operations- SSA, Novartis
Stefano Accorsi - Global Regulatory Affairs Policy and Intelligence Lead, Chiesi Farmaceutici
Ana Padua - Associate Director - Global Regulatory Affairs CMC Regulatory Intelligence, Merck Group
Jörg Stüben - Head of Regulatory Information Management and Senior Expert, Boehringer Ingelheim

13:45 - 14:30

The Small-to-Medium Enterprise Strategy Guide- Case Studies for Success in Regulatory Affairs and Clinical Trials

Doing more with less - learn practical strategies, cost-effective approaches and smart prioritiation frameworks to successfully navigate regulatory affairs
Hear from peers who have successfully brought products across multiple regions
Leverage external resources effectively including consultants, CROs and regulatory partners
Make informed buy v. build decisions for regulatory capabilities and infrastructure
Answer guiding questions driving everyday decisions - “How do I decide which markets to prioritise when we can’t afford to go everywhere? What systems and tools are essential v. nice-to-have? Where can I automate or streamline to save time?”

Andrey Mladenov - Regulatory Affairs Manager Medicine & Labelling, Dr. Falk Pharma

14:30 - 14:35

End of Conference

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