PROFORMA Qualified Person for Pharmacovigilance (QPPV) training

Between 11 and 21 January 2022, the PROFORMA project conducted a “training of trainers” workshop on the Qualified Person Responsible for Pharmacovigilance (QPPV). A QPPV is the main person responsible for handling the marketing authorisation holder’s (MAH) pharmacovigilance system effectively. A total of 45 participants successfully attended the training, which was facilitated by the Netherlands Pharmacovigilance Centre Lareb and Ghana Food and Drugs Authority. The goals of the QPPV training were to:

  • Understand the role and responsibilities of a qualified person for pharmacovigilance working for marketing authorisation holders
  • Understand the nature and purpose of medicinal products safety documentation such as periodic safety update report, periodic benefit/risk evaluation report and risk management plans
  • Understand the purpose and way of working of pharmacovigilance inspections and pharmacovigilance audits
  • Develop a national / country-specific QPPV training and implementation plan

The course participants were staff from national medicine and regulatory authorities (NMRAs): the Ethiopian Food and Drug Authority, Pharmacy and Poisons Board (Kenya), Rwanda Food and Drugs Authority and Tanzania Medicines & Medical Devices Authority and medical universities including Addis Ababa University (Ethiopia), Muhimbili University of Health and Allied Sciences (Tanzania), University of Nairobi (Kenya) and University of Rwanda.