Agenda
5:00 PM — 6:00 PM
Platform Orientation Session9:00 AM — 9:15 AM
Opening Session9:15 AM — 10:30 AM
Health Emergency Preparedness11:00 AM — 12:00 PM
Broadening the Vision – Bringing Imaging Into the Mainstream11:00 AM — 12:00 PM
COVID-19: Lessons Learnt so far in the Regulatory and R&D11:00 AM — 12:00 PM
Novel Manufacturing Approaches for Early Access and Sustained Supply11:00 AM — 12:00 PM
Vaccination: Exploring Risk Communication Needs12:00 PM — 12:30 PM
Speed Networking1:00 PM — 1:45 PM
Keynote: Transforming Healthcare Through Genomics and Precision Medicine2:15 PM — 3:15 PM
Globalisation of Pharmacovigilance and Impact of COVID-19 Pandemic5:15 PM — 6:00 PM
Networking - Bingo Get to Know the Exhibitors & Round Table Discussion5:30 PM — 6:00 PM
Transforming Regulatory Affairs6:00 PM — 7:00 PM
FDA Townhall9:00 AM — 10:15 AM
European Medicines Regulatory Network Strategy to 202511:00 AM — 12:00 PM
Enabling Cell and Gene Therapies: Creating an Appropriate Framework11:00 AM — 12:00 PM
Opportunities for Regulatory Dialogue to Accelerate Innovation in the EU11:00 AM — 12:00 PM
PMDA Updates12:00 PM — 1:00 PM
PharmaLedger - Demonstrating the vision of Blockchain Enabled Healthcare12:00 PM — 12:30 PM
Speed Networking2:00 PM — 2:50 PM
Poster Session 1 – Regulatory and Health Policy3:00 PM — 4:00 PM
ATMP Regulation 2.0 – Is the System Fit as is?3:00 PM — 4:00 PM
Trans-Diagnostic Drug Development Beyond Oncology3:00 PM — 4:00 PM
Value Communications and Negotiations – Are You Prepared?4:00 PM — 4:30 PM
Endotype Approach for Drug Development4:30 PM — 5:30 PM
De-risking Regulatory Strategy for ATMPs4:30 PM — 5:30 PM
Unmet Medical Need6:15 PM — 7:15 PM
GMPs for Investigational Products to Enable Rapid Patient Access9:00 AM — 10:15 AM
Medicines Shortages Changing the Paradigm from Mitigation to Prevention10:15 AM — 11:00 AM
Poster Session 2 – Safety and Pharmacovigilance11:00 AM — 12:15 PM
Opportunities and Challenges of RWE to Support Regulatory Decision-Making11:00 AM — 12:00 PM
RWE4 Decisions12:00 PM — 12:30 PM
Speed Networking1:00 PM — 2:00 PM
Building Effective Collaboration for Mutual Value Creation in Healthcare1:00 PM — 2:00 PM
Early Access CMC Approaches: EMA Toolbox Guidance 20212:00 PM — 2:30 PM
The Value of Strategic Partnerships: From Nice to Have to Necessity2:30 PM — 3:45 PM
Pharmaceutical science, innovation and social policy 20304:00 PM — 4:20 PM
Arisglobal Webinar: Overcome Site Regulatory (ISF) Issues5:30 PM — 6:15 PM
Networking - Round Table Discussion6:15 PM — 7:15 PM
Regulatory Science Dialogue9:00 AM — 10:00 AM
Cloud-based Submissions; from Principles to Practice10:45 AM — 12:00 PM
Changes in PV and the Impact of EU PV Legislation on Patient Safety12:00 PM — 12:30 PM
Speed Networking1:00 PM — 2:00 PM
Nitrosamines: Traceability / Sensitivity - What is Good Enough?1:00 PM — 2:15 PM
Reliance: The Key to Smart Regulation?2:00 PM — 2:30 PM
Monitoring and Surveillance in the Marketing of Medical Devices2:30 PM — 3:45 PM
COVID-19, An Opportunity to Step Up International Collaboration3:45 PM — 4:30 PM
Poster Session 3 – Clinical Development & Value and Access6:15 PM — 7:15 PM
MHRA Townhall: MHRA globally - Past, Present and Future9:00 AM — 10:00 AM
Engaging in the EU Regulatory Network: Member State Journeys9:00 AM — 10:00 AM
Singapore Townhall10:00 AM — 10:30 AM
COVID-19 and Beyond: Delivering Complex and Innovative Trials10:45 AM — 11:45 AM
Cross-border Access to ATMPs in the European Union10:45 AM — 12:00 PM
Refocus on Unmet Public Health Challenges – Who should Lead the Way?10:45 AM — 11:45 AM
The Eurasian Union Regulatory Framework - Now a Reality12:00 PM — 12:30 PM
Speed Networking1:00 PM — 2:00 PM
Digital Risk Minimization Tools1:00 PM — 2:00 PM
ePI – Setting Tomorrow’s Labelling and Regulatory Operations Framework1:00 PM — 2:00 PM
Unlock the Potential of Emergent Cell Therapies4:00 PM — 4:15 PM
Closing SessionHave an account?