Omar Tounekti

Company: Health Canada

Job title: Manager, Cell, Gene Therapies & Radiopharmaceuticals Division

Seminars:

Panel Discussion: From First Filing to Final Approval: Inside the Regulatory Journey of Cell & Gene Therapies 9:00 am

Key inflection points, setbacks, and accelerators across IND, BLA, and global filings Building productive relationships with regulators across regions – what worked, and what didn’t? Managing internal alignment and external expectations during late-stage development and approvalRead more

day: Conference Day One

Global Regulatory Alignment for Cell & Gene Therapies: Opportunities & Obstacles Beyond the FDA 9:00 am

As advanced therapies progress toward global development and commercialization, regulatory divergence remains a major challenge. This session will explore how developers are navigating inconsistent expectations across regions, and where opportunities lie to optimize patient access and streamline approvals beyond the U.S. Key regulatory misalignments between major agencies (e.g., EMA, PMDA, MFDS, NMPA, Swissmedic) and how…Read more

day: Pre-Conference Workshop Day

Evolving CMC Expectations for Cell & Gene Therapies: From Initial Filing to Post-Approval Change 10:00 am

Highlighting Health Canada’s approach to comparability and post-approval manufacturing changes Addressing the challenges of scaling CMC data from early-phase to BLA for complex gene therapy platforms Sharing insights on dossier readiness, common deficiencies, and opportunities for regulatory efficiencyRead more

day: Conference Day Two