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Adverse Event Guidelines

Latest ABPI/BHBIA Guidance - NEW August 2018

Guidance notes on collecting adverse events, product complaints and special reporting situations during market research

You can now download the revised August 2018 Guidance, produced by the BHBIA's Ethics & Compliance Committee in conjunction with the ABPI PEN (Pharmacovigilance Expert Network).

What’s changed?

  • The key change is that when AEs are collected directly from patients or consumers, market researchers now need if possible to collect the patient/consumer’s contact details and forward these details to the MAH pharmacovigilance (PV) team so that they can follow up where needed. This change was necessary to allow our PV colleagues to meet their EMA (European Medicines Agency) obligations.
  • We have updated the guidance in line with GDPR/DPA 2018 requirements and provided a new Annex ‘Key points on handling personal data for AEs, PCs and SRSs’
  • Another change is in the terminology used - throughout the guidelines we now talk about AEs (adverse events), PCs (product complaints) and SRS (special reporting situations), reinforcing that the guidelines apply to all 3 types of events.
  • We have also refreshed the layout and style of the Guidance so that it is easier to navigate and read.

The new Guidance notes explain what you need to do, as well as how to manage the new data protection requirements.

We understand that implementing the new Guidance may require some practical changes to pharma company and agency processes, so members have until the end of September to get plans in place, after which the new guidance needs to be operational.

The following associated resources are available as word documents, for your convenience when adapting for specific projects:

AE/PC/SRS Data Collection Form

AE/PC/SRS Reconciliation Form

Other resources to help you with collecting adverse events, product complaints and special reporting situations:

  • Market Research Quick Guide - AE/PC/SRS Collection from Market Research (One of our series of Quick Guides - for basic ready-reference information on key MR topics)

Keeping you informed about changes in the UK legal and ethical environment

Keeping you informed about changes in the UK legal and ethical environment

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