ABPI revises guidance for Pharmacovigilance in Market Research

The Association of the British Pharmaceutical Industry (ABPI) and the British Healthcare Business Intelligence Association (BHBIA) have produced a revised version of their guidance on collecting adverse events, product complaints and special situation reports during market research programmes (MRPs). The guidance document was first issued in October 2009, and is now version 4, which took effect from the beginning of October 2018.

Changes include the collection of contact details when information is collected directly from patients/consumers in order to enable the appropriate follow-up of adverse events by the marketing authorisation holder, and changes related to personal data protection.

The guidance document contains informative annexes, including suggested wording for the contract with the Market Research Agencies, templates for data collection and reconciliation forms, and interview scripts covering a range of scenarios.

The ABPI and BHBIA have worked on the guidance to ensure the scope of the guidance is clear in terms of market research types, market research methodologies, project types and mediums, and to make the remit of the researcher and the data collection process clear.

Information on the BHBIA website includes templates for data collection and reconciliation forms, suggested wording for market research materials, and a series of guides.

To view the guidance notes on collecting adverse events, product complaints and special reporting situations during market research, please click here.