Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue Based Products (HCT/Ps) 2016 covers topics such as:
- 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)
Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue Based Products (HCT/Ps) 2016 brings together 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