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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 (Hrvatska)
Amira Deia Younes
Director, Eastern Europe, Middle East & Africa (EEMEA) 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)
Supporting Countries’ Accession to the EU
Martin Harvey Allchurch, LLM
European Medicines Agency, Netherlands
Head of International Affairs
Reliance and Worksharing: WHO initiatives to support countries to implement Reliance
Samvel Azatyan, MD, PhD
World Health Organization (WHO), Switzerland
Team Lead, Regulatory Convergence and Networks (RCN/REG)
Benchmarking – The ALIMS journey in reaching maturity level 3
Jadranka Mirkovic
Medicines and Medical Devices Agency of Serbia (ALIMS), Serbia
Head of the Humane Medicines Centre
Industry’s perspective on Reliance: best practices, challenges, and recommendations
Angelika Joos, MPharm
MSD, Belgium
Executive Director, Global Regulatory Policy
Accelerate Regulatory Approvals using Reliance - Case Studies on Approval Timelines with and without Reliance applied to IMAs and PACs
Francesca Mangia, PhD
F. Hoffmann-La Roche Ltd, Switzerland
Regulatory Affairs International Operations Manager
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