Join regulatory leaders from around the world for an engaging panel discussion on the current and future of global regulatory practices. The session will address how rapid advances in pharmaceutical science, novel technology, new modalities, analytics, data management, and regulatory collaboration and submissions can be accepted globally and explore how experiences can inform a more agile, unified regulatory future. 

- Agency Collaboration & Harmonization: Insights into regional and international efforts like ICH, WHO, ICMRA, and other pilot programs that are paving the way for increased regulatory alignment. 

- Innovative Pathways: Discover strategies to accelerate acceptance of advanced technologies and novel modalities through streamlined submissions, inspections, and approvals. 

- Vision for the Future: Progress toward the “One Dossier, One Submission, One Review, One Inspection, One Approval” model, with updates on ICH M4Q (R2), ICH Q12, PQKM, and CMC submission alignment. 

Attendees are invited to share challenges, ideas and solutions to help build a more collaborative and efficient global regulatory ecosystem. 

Session Panelists:

Ahmet Ayar, Turkish Medicines and Medical Devices Agency (TITCK)

Jorge Canales Pacheco, ISP-Instituto de Salud Publica de Chile

Elana Cherry, Health Canada

David Kaslow, CBER, FDA

Claudia Müller, Swissmedic

Theresa Mullin, CDER, FDA

Takashi Ogawa, (PMDA) Pharmaceuticals and Medical Devices Agency

Mphako Ratlabyana, South African Health Products Regulatory Authority

Cecilia Tami

Appearances