Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue Based Products (HCT/Ps) 2016

Key Topics

• Regulatory recommendations regarding investigating and reporting adverse reactions
• Background and scope of the guidance for industry released March 2016
• What to expect when an establishment is investigating an adverse reaction
• Investigating complaints of adverse reactions concerning HCT/Ps
• When and how to submit reports of adverse reactions
• Notifying and sharing information with other establishments that are known to have recovered HCT/Ps from the same donor
• Completing form FDA 3500A (MedWatch)

Who should Attend

Attendees from:

• Quality professionals working in HCT/P establishments
• Individuals working at the regulatory affairs of any HCT/P establishment
• Physicians and consumers using HCT/Ps
• Medical Director or physicians who oversee HCT/P establishments