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safety competenceRegulators require competence (from the Latin competere: to be able to do something, to come together) from Marketing Authorisation Holders in all aspects of Pharmacovigilance. Patients expect it as a given.

Pharmacovigilance GmbH & Co. KG offers a combination of more than 50 years of Safety Competence, in addition to medical qualifications. This comprises experience in interventional and non-interventional clinical studies, Drug Safety Monitoring Boards, Risk Management Plans, Pharmacovigilance (PV) systems, inspections, data entry and assessment, periodic reports, signal detection, recalls etc. (see below).

As an example of regulators´ expectations Guideline on good pharmacovigilance practices (GVP) Module I – Pharmacovigilance systems and their quality systems may be a case in point:

‘The marketing authorisation holder shall ensure that the QPPV has acquired adequate theoretical and practical knowledge for the performance of pharmacovigilance activities. The QPPV should have skills for the management of pharmacovigilance systems as well as expertise or access to expertise in relevant areas such as medicine, pharmaceutical sciences as well as epidemiology and biostatistics. Where the QPPV has not completed basic medical training, the marketing authorisation holder shall ensure that the QPPV is assisted by a medically trained person and this assistance shall be duly documented.’

scratch PV has experience in including (but not limited to) the following areas:

  • Implementation, operation and management of a PV system (inspected successfully), including SOPs
  • Creation/edit and maintenance of the Pharmacovigilance System Master File (PSMF)
  • Qualified Person responsible for Pharmacovigilance (QPPV) and back-up procedures, available to regulators 24/7
  • Availability and management of an (inspected) safety database, incl. electronic reporting
  • Management of Individual Case Safety Reports (ICSRs), including follow up and reporting to regulators (for Serious Adverse Events from clinical trials as well as for postmarketing cases)
  • Management of Drug Safety Monitoring Boards (DSMBs)
  • Creation and edit of periodic Pharmacovigilance reports, e.g. Periodic Safety Update Reports / Periodic Benefit Risk Evaluation Reports, Development Safety Update Reports
  • Creation/edit and maintenance of Risk Management Plans (RMPs)
  • Responding to Pharmacovigilance requests and issues raised by regulators, e.g. EU Referrals or recalls
  • PV related audits; support before, during and after PV inspections by regulators
  • PV Due Diligence, e.g. in association with inlicensing or merger activities
  • Interim PV management or operational support
  • PV training
  • Risk simulations
  • Management coaching / strategic PV consultancy