Qualified person for pharmacovigliance

All pharmaceutical companies need one: a qualified person for pharmacovigilance (QPPV) as defined in EU Directive 2001/83/EC is obliged to run the pharmacovigilance system for pharmaceutical manufacturers. The QPPV has to collect and evaluate reports on drug risks and coordinate any necessary actions, and even more.

Pharmaceutical companies throughout Europe require a QPPV. Regulation (EC) 724/2004 and EU Directive 2001/83/EC, which has been implemented into national law, are the legal basis for this requirement. As a result, the QPPV must be available 24/7, 365 days a year. Diapharm is the perfect partner for pharmaceutical companies that need to cover peaks and vacation times or wish to outsource QPPV responsibilities.

Diapharm is there to help

This service helps our clients fulfil European and national pharmacovigilance requirements without having to add additional capacities while guaranteeing QPPV availability as required:

  • The QPPV for the European Union
  • The national QPPV/local safety officer in EU member states, in which local representatives are required, such as the "Stufenplanbeauftragter" as defined in sect. 63a of the German Drug Law (AMG)
  • Efficiently ensuring that regulations are complied with
Dr. Christoph Buss
Associate Director Regulatory Affairs & Pharmacovigilance

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