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Hotel Ilunion Alcora Sevilla

Sep 27, 2022 8:30 AM - Sep 28, 2022 3:00 PM

San Juan de Aznalfarache, 41920 Sevilla, Spain

Accelerating CMC Workshop

This Workshop will focus on the currently most relevant topics in the CMC (Chemistry, Manufacturing and Controls) regulatory space with a global perspective.

Session 1, part I: Reliance & Work-sharing

Session Chair(s)

Susanne  Ausborn, PhD

Susanne Ausborn, PhD

Global Head International Regulatory Policy

Roche, Switzerland

Victoria  Palmi-Reig

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


Marie  Valentin, PharmD

Where do we stand with Reliance?

Marie Valentin, PharmD

WHO, Switzerland

Team Lead, Facilitated Product Introduction

Myriam  Archambault, MBA, MSc

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

Joel  Raymond

ACCESS – A Successful example of Work-sharing: Where is it heading next?

Joel Raymond

Health Canada, Canada


Victoria  Palmi-Reig

Collaborative review & Expansion of EMA Open Pilot to the ICMRA pilot

Victoria Palmi-Reig

European Medicines Agency, Netherlands

International Affairs

Mike H Saleh, MS

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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