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Minutes from affiliate PV/RA meetings

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  • tina
    14/05/2020 21:03
    Which reference would be the most appropriate to use when an affiliate is not taken minutes after weekly PV/RA meeting ? Is it only always necessary to keep minutes such meetings or does it depend on what is discussed at these meetings? Many thanks for your advice.
  • Henrieke
    14/06/2020 16:05
    Hi Tina, I would expect that company standard procedures define how specific meetings are recorded and what should be documented to ensure appropriate documentation of PV-related assessments, decision-taking and actions, in order to follow applicable requirements and to ensure evidence thereof exists. Assuming the PV system follows EU legislation, I would refer to EU PV Module I section I.B.10 Record Management. As per this section, "a record management system shall be put in place for all documents used for pharmacovigilance activities, ensuring their retrievability as well as traceability of the measures taken to investigate safety concerns, of the timelines for those investigations and of decisions on safety concerns, including their date and the decision-making process." Check this module for further details.
  • Tina
    20/06/2020 12:32
    Many thanks for your good feedback.
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