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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 II: 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


Nélio Cézar  de Aquino, MSc

Global Regulators Experience with different Pathways

Nélio Cézar de Aquino, MSc

ANVISA, Brazil

General Manager of Medicines

Hanan  Amin Rizk Hamoda

Global Regulators Experience with different Pathways

Hanan Amin Rizk Hamoda

Egyptian Drug Authority, Egypt

Head of Centeral adminstration of Pharmaceutical Products

Amina  Al Haj Hussein

Global Regulators Experience with different Pathways

Amina Al Haj Hussein

Jordan Food and Drug Administration (JFDA), Jordan

Regulatory Affairs Specialist

Mijeong  Kim

Global Regulators Experience with different Pathways

Mijeong Kim

MFDS, Korea, Republic of

Director- Pharmaceutical Standardization Division, NIFDS

Saeed  Al Awadh

Global Regulators Experience with different Pathways

Saeed Al Awadh

Saudi Food and Drug Authority, Saudi Arabia


Isabelle  Colmagne-Poulard, PharmD, MBA, MSc

Reliance and Work-sharing in Action - IMAs and PACs case studies

Isabelle Colmagne-Poulard, PharmD, MBA, MSc

Merck, Switzerland

Head, International Global Regulatory & Scientific Policy

Thierry  Gastineau, PharmD

A Pilot on Reliance for a Post-Approval Change

Thierry Gastineau, PharmD

Sanofi , France

Global Head Quality Innovation, Culture & Engagement

Dirk  Leutner, PhD

Panel discussion with Q&A, with the additional participation of:

Dirk Leutner, PhD

EDQM/Council of Europe, France

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