アジェンダ
9:00 AM — 7:00 PM
Leader of Tomorrow 20249:00 AM — 10:30 AM
Opening Plenary and Keynote Address10:35 AM — 10:55 AM
The Future of Regulatory Documentation with Generative AI11:00 AM — 12:20 PM
Focus Group: Are your collaborations ‘igniting change'? If so, how? If not, why?12:40 PM — 1:40 PM
Live Oral Poster Presentations I1:50 PM — 3:00 PM
AI in Medicines Lifecycle1:50 PM — 3:00 PM
Collaborative Review & Reliance – Grasping the Opportunity1:50 PM — 3:10 PM
DIA Startup Accelerator1:50 PM — 3:00 PM
International Regulation and Harmonisation: A Global Approach1:50 PM — 3:00 PM
Risk Minimisation Measures: Future Collaborative Solutions in Europe1:50 PM — 3:00 PM
South-Eastern Europe Townhall3:30 PM — 4:50 PM
Complexity: Interplay and Interface of Different Legislations3:30 PM — 4:40 PM
Darwin EU: How RWE Is Transforming Regulatory Decision Making?3:30 PM — 4:40 PM
Futureproofing of the EU Clinical Trials Regulation (CTR)3:30 PM — 4:40 PM
Middle East Townhall: Future-Proofing the Regulatory Framework3:30 PM — 4:40 PM
PMDA Townhall3:30 PM — 4:40 PM
Preference Studies in Regulatory and Payers' Decisions: Are We Ready?5:10 PM — 6:40 PM
Digital Transformation in EU Regulatory Space5:10 PM — 6:40 PM
Driving R&D to Meet Societal Needs9:00 AM — 10:10 AM
China Townhall9:00 AM — 10:10 AM
Defining Unmet Medicinal Need and Implications for Regulatory Strategy9:00 AM — 10:10 AM
Life-Cycle Management and CMC dossier9:00 AM — 10:10 AM
Medical Devices in Clinical Trials9:00 AM — 10:10 AM
MHRA Townhall9:00 AM — 10:10 AM
Registries: Solving the Real Life Challenges9:00 AM — 10:10 AM
RWE Supporting HTA/Payers Determine the Value of Highly Innovative Medicines10:15 AM — 10:35 AM
Phased Reviews10:40 AM — 11:50 AM
Europe on the Biopharmaceutical Innovation Map10:40 AM — 11:50 AM
IVDR (In-Vitro Diagnostics Regulation)10:40 AM — 11:50 AM
Sustainability and CMC (Chemistry, Manufacturing and Controls)10:40 AM — 11:50 AM
Thrive Through Reliance Implementation12:00 PM — 1:00 PM
IHI in a Nutshell12:00 PM — 1:00 PM
Live Oral Poster Presentations II1:10 PM — 2:40 PM
ACT EU and the Future of Clinical Research in Europe1:10 PM — 2:40 PM
Global Innovation in Manufacturing and CMC3:00 PM — 6:30 PM
3:10 PM — 4:20 PM
Clinical Trials with Decentralised Elements3:10 PM — 4:20 PM
FDA Townhall3:10 PM — 4:20 PM
Get to Decide: How to Lead Better Using Decision Science3:10 PM — 4:20 PM
How to Build a Sustainable Pharmacovigilance Ecosystem?4:25 PM — 4:45 PM
Certified AL in Life Science Operations Sponsored by NTT DATA4:25 PM — 4:45 PM
Trans and Gender Diversity in Pharmacovigilance and Labelling4:50 PM — 6:00 PM
AI/Automation in ICSRs and Signals4:50 PM — 6:00 PM
Chat with Professionals – Career Twists and Turns4:50 PM — 6:00 PM
Latin America Townhall4:50 PM — 6:00 PM
Methodologies Session9:00 AM — 10:10 AM
AI in Medicines Regulation: Beyond our Imagination9:00 AM — 10:10 AM
Drug Repurposing: Opportunities & Challenges9:00 AM — 10:10 AM
Enabling Technology for Product Lifecycle Management in Europe9:00 AM — 10:10 AM
HTA Townhall – Ready for 2025 EU Joint Clinical Assessment9:00 AM — 10:10 AM
ICH Townhall, Part 19:00 AM — 10:10 AM
Medical Device Software & Connected Devices10:40 AM — 11:50 AM
Digital Transformation Showcase10:40 AM — 11:50 AM
EU Combination Products – Opportunities and Challenges10:40 AM — 11:50 AM
How to De-risk Early Development?10:40 AM — 11:50 AM
ICH Townhall, Part 210:40 AM — 11:50 AM
PIP Focusing on Child-Centric Medicines Developments10:40 AM — 11:50 AM
Regulatory Sandbox10:40 AM — 11:50 AM
The EU HTA Procedure: Ensuring Timely Access to OMPs and ATMPs12:00 PM — 1:00 PM
Harmonizing Your Regulatory Submissions for Pharmacovigilance & RMPs12:00 PM — 1:00 PM
Live Oral Poster Presentations III1:20 PM — 2:50 PM
Sustainability - A Call to Action!3:00 PM — 4:00 PM
Closing Session