ISCT Global Regulators Summit
Optimizing Accelerated Pathways to Fast-Track Product Approvals
Tuesday, May 7, 2025 • Closed, Invitation-Only Event
The 3rd Annual Global Regulators Summit will bring together representatives from international regulatory organizations to jointly address and enhance accelerated regulatory pathways for cell and gene therapy products. The discussion will focus on the evolving regulatory landscape, challenges, and the future directions for accelerated pathways.
The summit will address:
- Review current accelerated pathways that are in place for approval of cell and gene therapy products
- Examine the key challenges faced by the regulatory agencies in ensuring that these pathways truly accelerate product approval timelines without compromising safety and efficacy
- Identify specific areas for enhancing the effectiveness and post-approval validation of expedited regulatory pathways
The unprecedented event in 2024 brought together key regulatory leaders and experts from 19 global regulatory agencies and government organizations to address and enhance understanding of global regulatory challenges in the development, manufacture, and accessibility of cell and gene therapy products for treating rare diseases while also discussing current global policies and strategies. Agencies and organizations included DOH (United Arab Emirates), EDQM (EU), CAT-EMA (EU), MHRA (United Kingdom), NoMA (Norway), SAM (Estonia), SFDA (Saudi Arabia), Swissmedic (Switzerland), CBER-FDA (USA), Health Canada, British Columbia Provincial MoH (Canada), CDE (Taiwan), HSA (Singapore), ICMR (India), NPRA (Malaysia), PMDA (Japan), TFDA (Taiwan), TGA (Australia), and ISPCH (Chile).