Plenary Session 3 - Navigating the Regulatory Landscape: Global Convergence and Innovation in Biopharmaceutical Manufacturing

In this session, regulatory leaders from the EMA, Health Canada, PMDA, Health Canada, and international health authorities including WHO will delve into the challenges hindering the path to regulatory reliance and approval of advanced technologies. By sharing their insights and experiences, they will illuminate potential solutions to overcome these obstacles and accelerate the journey towards a unified "One Submission/One inspection/One Assessment" approach. 

Join us as we explore the latest advancements in technology and reliance that are reshaping the regulatory landscape. Together, we can foster a collaborative environment that benefits all companies and countries. 

Ahead of and during the session, we invite attendees to share their most pressing challenges and transformative solutions. Your contributions will help shape a more productive and insightful discussion. 

Key Highlights: 

- Regulatory Reliance Progress: Are recent advancements in reliance tools and pilots being shared across all regions and companies? 

- Future of Biopharmaceutical Manufacturing: What does the future hold for biopharmaceutical manufacturing, and how can regulators support these changes? 

- Advanced Technologies: How are regulators incorporating advancements in technology to improve efficiency and speed to patient? 

- Global Convergence: What steps can be taken to promote greater convergence and collaboration among regulatory authorities? 

Session Panelists:

Rogério Gaspar, World Health Organization

Yasuhiro Kishioka, Pharmaceuticals and Medical Devices Agency (PMDA)

Anabela Marçal, European Medicines Agency (EMA)

Claudia Müller, Swissmedic

Sophie Sommerer, Health Canada