Global Regulatory Perspectives
The ISCT Global Regulatory Perspectives (GRP) represents the diverse activities and partnerships between international regulatory bodies, industry, clinicians and academia. The ISCT GRP steering group is comprised of representatives the Society's Legal and Regulatory Affairs Committees from Asia, Australia, Europe, North America, and South and Central America. The key output from this joint working group is the GRP Workshop.
The flagship GRP Workshop is an annual one-day workshop that is run in tandem with the Society's Annual Meeting. Unique to this program is that it brings together regulators from North America, Europe, Asia, South and Central America, and Australia/New Zealand. The workshop is aimed to provide participants with viewpoints and perspectives from international regulators of cell therapy products. It is also a highly interactive program as speakers and participants are encouraged to participate in various hypothetical case studies throughout the program.
Topics of discussion in past workshops have included:
- Regulatory Considerations for Gene Therapies incorporating Human Genome Editing
- Manufacturing Challenges during Accelerated Development of CGT Products
- Product approvals and market authorization
- Materials standardization and qualification
- Characterization and comparability
- Regulatory updates from emerging markets