Navigating Regulatory Challenges in Donor Selection for Allogeneic Therapies
Time: 1:31 pm
day: Post-Conference Day
Details:
Participants will gain an in-depth understanding of the primary regulatory challenges encountered in the donor selection process including harmonizing standards and ensuring compliance with stringent regulatory standards in the United States, Europe, and Asia. Participants will engage in practical discussions to develop compliant documentation and learn how to prepare for regulatory audits and inspections. By the end of the workshop, participants will be equipped with practical strategies to navigate the regulatory landscape of donor selection for allogeneic therapies.
Join this workshop to:
- Understand the key regulatory challenges in the donor selection process for allogeneic therapies
- Learn best practices for ensuring compliance standards on starting materials across US, Europe and Asia
- Define standards across donor screening, testing, and quality assurance
- Develop strategies for effective documentation and record-keeping
- Implement ethical considerations and donor safety measures
