Session 1, part II: Reliance & Work-sharing

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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, MPharm

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