Adverse events and adverse reactions can be a complicated issue in the field of cellular therapy. This session will examine expected and rare events associated with HCT/Ps and review how each should be reported. Roles and responsibilities of the clinical, collections, and processing laboratory will be illustrated. Using a case study approach reporting to regulatory agencies, and involvement of the principle investigator and internal review board will be discussed.




This session offers Self-Assessment Module (SAM) credit. Please complete the post test to receive SAM credit.