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Session 10: Global Regulators in Focus: Key Updates Shaping the Future of Regulation
Session Chair(s)
Lindsay Fitzgerald
Delivery Manager, Astrix, United States
Tamei Elliott, MS
Director, Global Scientific Content, DIA, United States
Receive the latest updates from international regulators about recent and future developments. This session provides attendees the opportunity to ask regulators questions directly. Please note: due to the high volume of questions, not all will be answered live at the forum. We encourage audience members to submit questions in advance via the DIA mobile app.
Kristiina Puusaari, European Medicines Agency
Update on eCTD v3.2.2 & v4.0 in APAC Region
Handsome Ji, Pfizer
Key Updates Shaping the Future of Regulation
Andrea Johnson, Medicines and Healthcare products Regulatory Agency (MHRA)
Learning Objective : - Discuss how regulatory agencies are transforming their operating models to adapt to emerging industry needs
- Explain modernization efforts within regulatory infrastructure, focusing on how digital tools, data capabilities, and streamlined processes support more efficient review and submission management
- Recognize the importance of governance and patient centric principles in shaping the next phase of regulatory review
Speaker(s)
Kristiina Puusaari, MBA, PMP
Digital Business Transformation Programme eSubmission Senior Coordinator, European Medicines Agency, Netherlands
Speaker
Andrea Johnson
Deputy Director of Future System Business Requirements, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Key Updates Shaping the Future of Regulation
Shenqi (Handsome) Ji
Publishing Regional Director, Asia, Global Regulatory & International Operations, Pfizer, China
Update on eCTD v3.2.2 & v4.0 in APAC Region
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