BHBIA/ABPI guidance on reporting adverse events, product complaints and special reporting situations
The latest Guidance notes on collecting adverse events, product complaints and special reporting situations during market research were produced in August 2018 by the BHBIA in conjunction with the ABPI PEN (Pharmacovigilance Expert Network).
This document replaces all previous versions.
The Guidance Notes explain:
- What you need to do to meet your obligations to drug safety;
- Specific requirements introduced in 2018 that apply when collecting Adverse Events (AEs), Product Complaints (PCs) and Special Reporting Situations (SRSs) directly from patients/consumers;
- How to manage data protection requirements when forwarding AEs, PCs and SRSs.
Other useful resources:
The following associated resources are available as word documents, for your convenience when adapting for specific projects:
Our AE/PC/SRS reporting FAQ resource is a selection of real-life queries
from members and the responses from our Ethics Advisor. It supplements
the Guidance Notes, but does not cover all topics – please always check
the main Guidance Notes document first.