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Session 1, part II: 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)
Global Regulators Experience with different Pathways
Nélio Cézar de Aquino, MSc
ANVISA, Brazil
General Manager of Medicines
Global Regulators Experience with different Pathways
Hanan Amin Rizk Hamoda
Egyptian Drug Authority, Egypt
Head of Centeral adminstration of Pharmaceutical Products
Global Regulators Experience with different Pathways
Amina Al Haj Hussein
Jordan Food and Drug Administration (JFDA), Jordan
Regulatory Affairs Specialist
Global Regulators Experience with different Pathways
Mijeong Kim
MFDS, Korea, Republic of
Director- Pharmaceutical Standardization Division, NIFDS
Global Regulators Experience with different Pathways
Saeed Al Awadh
Saudi Food and Drug Authority, Saudi Arabia
Expert
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
A Pilot on Reliance for a Post-Approval Change
Thierry Gastineau, PharmD
Sanofi , France
Global Head Quality Innovation, Culture & Engagement
Panel discussion with Q&A, with the additional participation of:
Dirk Leutner, PhD
EDQM/Council of Europe, France
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