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Session 1, part I: Reliance & Work-sharing
Session Chair(s)
Susanne Ausborn, PhD
Global Head International Regulatory Policy
Roche, Switzerland
Victoria Palmi-Reig
International Affairs
European Medicines Agency, Netherlands
This Session will bring together regulators from different jurisdictions around the globe and industry representatives to jointly discuss ongoing efforts to drive regulatory convergence and implement reliance pathways globally, aiming use regulatory resources more efficiently through collaboration.
Panelists will share their perspectives about work-sharing and/or reliance pathways using real life examples/ case studies and reflect on the value of collaboration and key learnings. Focus will be on barriers preventing efficient implementation of reliance pathways and on the definition of “sameness of the product” - as outlined in the WHO Good reliance practice.
- Which role does “sameness” play to decide if reliance pathways can be used? What are the perspectives of stakeholders on the definition of sameness?
- What are the expectations from the different stakeholders to optimally leverage the available reliance pathways?
- Which role can industry play to optimize the use of existing pathways and support efficient use of resources on both regulators and industry site
Speaker(s)
Where do we stand with Reliance?
Marie Valentin, PharmD
WHO, Switzerland
Team Lead, Facilitated Product Introduction
ACCESS – A Successful example of Work-sharing: Where is it heading next?
Myriam Archambault, MBA, MSc
Health Canada, Canada
Senior Regulatory Advisor, Office of Regulatory Intelligence and Risk Management
ACCESS – A Successful example of Work-sharing: Where is it heading next?
Joel Raymond
Health Canada, Canada
Manager
Collaborative review & Expansion of EMA Open Pilot to the ICMRA pilot
Victoria Palmi-Reig
European Medicines Agency, Netherlands
International Affairs
Product Sameness as Enabler for Reliance: What makes the Difference? – IFPMA Perspective
Mike H Saleh, MS
Pfizer, Inc., United States
Director, Global Chemistry, Manufacturing and Controls
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