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

Nina Cauchon

Appearances

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

Session Chairs

Speakers