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vertraegeGuideline on Good Pharmacovigilance Practices (GVP) has added focus on the overall pharmacovigilance (PV) system of the MAH, including distributors, license partners, and service providers. One major way of dealing with the complexities of such a system is the development of effective, useful, and sustainable PVAs.

There are, however, a few topics that lend themselves to misunderstandings and possible non compliances. A non comprehensive list of these would include:

  • List of relevant safety information (were all special situations included? How about occupational exposure and counterfeit product?)
  • Reasonable timelines (24 h?, seven working days?)
  • Sufficient time for translation by an experienced person
  • Local literature search
  • Responsibility for regulatory reporting – information to partner
  • Reconciliation – frequency, parameters, who is the owner, response time
  • Audits – who audits whom, how long, consequences
  • Escalation – what is the process if there is non agreement or non compliance
  • Review cycle of the PVA

has extensive experience in writing, editing and executing PVAs.

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