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ADVERSE EVENT REPORTING GUIDELINES - EphMRA

ADVERSE EVENT REPORTING GUIDELINESI ssued: September 202021 procedural guideline/guideline good pharmacovigilance p ractices gvp module vi collection management submission (accessed 05/02/2020) 2 The European Medicines website: 0b01ac0580b18c76 (accessed 05/02/2020) EphMRA ADVERSE EVENT REPORTING (AER) GUIDELINES These GUIDELINES provide the principle requirements of Pharmacovigilance (PV) REPORTING for individuals or organisations involved in market research (MR) activities within the healthcare industry. This includes those working for a Marketing Authorisation Holder (MAH), Market Research Organisation (MRA) or other organisations involved in MR activities. It applies to employees and contractors working with or for a MAH, MRA or other organisations engaged in MR. The principles relate to global PV requirements with particular reference to the European Medicines Agency s (EMA) Guideline on Good Pharmacovigilance practices (GVP), Module VI for the Collection, management and submission of reports of suspected ADVERSE reactions to medicinal products1.

2. ADVERSE EVENT – DEFINITIONS Adverse Event (AE) An Adverse Event is an unintended and unfavourable response to a medicine, whether or not considered to be related to the medicine (i.e. causal relationship). Special Reporting Situations (SRS) Situations where a medicine is used outside of the marketing authorisation, including:

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