Charter
The North American Legal and Regulatory Affairs Committee (NA LRA) of the ISCT serves the membership and others working in cellular therapy by providing information regarding U.S., Canadian and international regulations, standards, guidance documents and published best practices and by presenting the regulatory concerns of the membership back to Regulatory Agencies.
Projects & Objectives
- Cell Therapy Liaison Meeting: The NA LRA Lead Designate coordinates and hosts this annual closed meeting with the FDA in collaboration with 20+ stakeholder groups
- ISCT Annual Meeting: The NA LRA is actively involved in the organization of the ISCT Annual Meeting. The NA LRA topic interests are included in the the Quality and Operations Track. This committee also participates in the review of abstract submissions.
- ISCT Global Regulatory Perspectives (GRP) Workshop: The NA LRA is actively involved in the development of the annual GRP Pre-Conference Workshop that runs in conjunction with the annual meeting.
- Educational Webinars: The NA LRA is involved in the planning of online webinar seminars.
- NA LRA Watchdog: The committee develops frequent watchdog notifications of relevant FDA, Health Canada and related regulatory news updates to the membership. These watchdog announcements are featured in the Telegraft.