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REGULATORY TRACK - Session 1: Regulatory Convergence, Collaboration and Reliance - Part 1, a Global Perspective
Session Chair(s)
Maja Lovrek Romcevic, MPharm
Head of Medicines Authorisation Division, Agency for Medicinal Products and Medical Devices, Croatia
Amira Deia Younes
Director- Europe, Middle East & Africa (EMEA), Global Regulatory Policy, MSD, United Arab Emirates
While harmonisation and convergence have been pursued for many years by international initiatives, lessons learned from the pandemic have confirmed that increased international collaboration between regulators and the use of regulatory reliance pathways are essential to handle the increasing demand on regulatory science capacity and product complexity within Authorities, while ensuring faster regulatory approvals and allowing timely access of medicines to patients in need globally.
This session will include:
- EMA’s initiatives to support countries accession to the EU.
- WHO’s initiatives to support countries in implementing Reliance.
- ALIMS’s journey in reaching maturity level 3 and experiences from other Regions with Reliance.
- Industry’s perspective on Reliance, including best practices, challenges and recommendations for an attractive reliance model, while leveraging case studies showing different approval timelines with and without Reliance.
Speaker(s)
Martin Harvey Allchurch, LLM
Head of International Affairs, European Medicines Agency, Netherlands
Supporting Countries’ Accession to the EU
Samvel Azatyan, MD, PhD
Senior Adviser, Council For International Organizations of Medical Sciences (CIOMS), Switzerland
Reliance and Worksharing: WHO initiatives to support countries to implement Reliance
Jadranka Mirkovic
Head of the Humane Medicines Centre, Medicines and Medical Devices Agency of Serbia (ALIMS), Serbia
Benchmarking – The ALIMS journey in reaching maturity level 3
Angelika Joos, MPharm
Consultant, Consultant, Belgium
Industry’s perspective on Reliance: best practices, challenges, and recommendations
Francesca Mangia, PhD
Regulatory Affairs International Operations Manager, F. Hoffmann-La Roche Ltd, Switzerland
Accelerate Regulatory Approvals using Reliance - Case Studies on Approval Timelines with and without Reliance applied to IMAs and PACs
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