会议日程
9:00 AM — 12:30 PM
SC01: Choosing Measures of Treatment Benefit: Estimands and Beyond9:00 AM — 12:30 PM
SC02: Hot Topics in Pharmacovigilance9:00 AM — 12:30 PM
SC03: Introduction to the Regulation of Medical Devices and Medical Software11:00 AM — 12:30 PM
European Regulatory Town Hall Meeting2:00 PM — 3:30 PM
Opening Plenary4:30 PM — 6:00 PM
Benefit/Risk Communication: Towards a Patient-Centred Approach4:30 PM — 6:00 PM
Global Dossier for Clinical Development4:30 PM — 6:00 PM
Global Pharmacovigilance and Risk Management in 20204:30 PM — 6:00 PM
Information on Medicines for Lay Audiences4:30 PM — 6:00 PM
Innovation Through eHealth Data4:30 PM — 6:00 PM
Keynote Session: Headlines New EU MDR & EU IVDR9:00 AM — 10:30 AM
Current Trends and Solutions in Global Clinical Operations11:00 AM — 12:30 PM
Best Solutions for Master Data Management11:00 AM — 12:30 PM
Consultations for Combination Products and Substance-Based Medical Devices11:00 AM — 12:30 PM
Creating a Framework for Innovation II: Infrastructure and Collaborations11:00 AM — 12:30 PM
EU Clinical Trial Regulation and Its Implications11:00 AM — 12:30 PM
Optimising the Development of Paediatric Medicines11:00 AM — 12:30 PM
Update on PMDA Activities2:00 PM — 3:30 PM
Balancing Clinical Evaluations versus Clinical Studies2:00 PM — 3:30 PM
Brexit – Where Are We Now?2:00 PM — 3:30 PM
EU Telematics beyond Cost and Timelines2:00 PM — 3:30 PM
Immunogenicity Assessment – Risk-Based Approaches2:00 PM — 3:30 PM
Quality Standards across the Globe – Evolution and Enforcement2:00 PM — 3:30 PM
Real-World Evidence for the Future2:00 PM — 3:30 PM
The Future of the EU Orphan Drug Network4:00 PM — 5:30 PM
GCP Findings and the Benefit-Risk Balance4:00 PM — 5:30 PM
Interoperability: Avoiding Babylonian Confusion4:00 PM — 5:30 PM
Post-Market Surveillance and Vigilance – Globalisation and Data Pooling4:00 PM — 5:30 PM
Real World Evidence in Pharmacovigilance - Making the Most of the Data4:00 PM — 5:30 PM
The Patient at the Centre of Adaptive Approaches4:00 PM — 5:30 PM
Vaccine Pandemic Preparedness - New Approaches9:00 AM — 10:30 AM
Global Regulatory Convergence- State of Play and Outlook for the Future11:00 AM — 12:30 PM
From Inventive Ideas to Implemented Innovation11:00 AM — 12:30 PM
ICMRA - A Global Coalition of Medicines Regulators11:00 AM — 12:30 PM
IVD and Companion Diagnostics in the Era of Personalised Medicines11:00 AM — 12:30 PM
The 3R’s: Reinvigorating, Repurposing and Reclassification11:00 AM — 12:30 PM
The Importance of Good Communication in Risk Management11:00 AM — 12:30 PM
The Pillars of Decision Making: Regulators, HTAs, Payers / Budget Holders1:30 PM — 2:30 PM
Conference Insights and Outcomes – Rapid Fire Session