Plenary Session 2 - Transforming Global Regulatory CMC Practices in an Age of Revolutionary Innovation

This regulatory panel will bring together regulators from several global regions for an interactive discussion about evolving practices and initiatives. 

Current trends in agency-agency and agency-industry collaborations, including:  

- Discussions on the role of regional and international harmonization and regulatory convergence initiatives, including ICH, WHO, and regional initiatives  

- Sharing experiences from collaborative reviews, e.g., ICMRA pilots, Project Orbis/Access Consortium and other collaborative and reliance pathways 

Accelerating the pace of acceptance for innovative solutions, including:  

- Achieving the blue-sky vision “One dossier, one submission, one review, one inspection, one approval”, e.g., ICH M4Q revision, CMC dossier content alignment, ICH Q12 benefits, Accumulus 

- Addressing how rapid advances in pharmaceutical science, novel technology, new modalities analytics, data management, and regulatory concepts can be accepted globally. 

Session Speakers:

Update From WHO: Global Perspective on Regulatory Harmonization and Convergence to Support Reliance

Samvel Azatyan, WHO - World Health Organization

Additional Panelists:

Nelio Aquino, ANVISA

Yasuhiro Kishioka, PMDA - Pharmaceuticals and Medical Devices Agency 

Steve Kozlowski, CDER, FDA

Ingrid  Markovic, CBER, FDA

Nino Mihokovic, EMA - European Medicines Agency