European Pharmaceutical Market Research Association (EphMRA) has revised the Adverse Event Reporting (AER) Guidelines in September 2021 (click here).
The guideline provide the recommendations for Pharmacovigilance (PV) reporting for individuals or organizations involved in market research (MR) activities within the healthcare industry which is often an area of confusion for pharmaceutical companies. This includes guidance for Marketing Authorization Holder (MAH), Market Research Organization (MRA) or other organizations involved in MR activities. It it covers employees and contractors working with or for a MAH, and organizations engaged in market Research.
(EMA) Guideline on Good Pharmacovigilance practices (GVP), Module VI for the ‘Collection, management, and submission of reports of suspected adverse reactions to medicinal products.