S0406 - International Collaboration (Orbis/Access) Townhall

About this session

The landscape of pharmaceutical regulation is becoming increasingly complex, demanding innovative approaches to ensure efficient and effective market authorizations.
This session will explore the pivotal role of international collaboration in pharmaceutical regulation, with a focus on the Access Worksharing Consortium and Project Orbis. Experts from Swissmedic (Switzerland), the MHRA (UK), and industry representatives from Roche (Canada) and Lundbeck (Denmark) will discuss how these frameworks streamline regulatory processes, minimize duplication of efforts, and expedite patient access to essential medicines across borders.

Programme:
- 4. Panel Discussion on Access Consortium and Project Orbis — Christina Hyldgaard Olesen, Jon Beaman
- 2. Access Consortium and Project Orbis - Regulator’s Perspective — Cornelia Bigler
- 3. Industry experiences with Access & Orbis — Donna Janzen
- 1. Introduction — Simon Dalla Torre di Sanguinetto

Speakers

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  Simon Dalla Torre di Sanguinetto

  Head of Regulatory Operations and Development · Swissmedic

  Chair

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  Jon Beaman

  Deputy Director for Innovative Medicines (Healthcare Quality & Access) · MHRA

  Panelist

• CB

  Cornelia Bigler

  Regulatory Manager, Deputy Head Unit 4 Regulatory Assessment · Swissmedic

  Speaker

• 

  Donna Janzen

  Director, Regulatory Affairs · Hoffmann-La Roche, Ltd.

  Speaker

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  Christina Hyldgaard Olesen

  Regulatory Strategy Lead · H. Lundbeck A/S

  Panelist