Pharmacovigilance: function as QPPV
All pharmaceutical companies need one: a qualified person for pharmacovigilance as defined in Section 63a of the German Drug Law (AMG) is obliged to run the pharmacovigilance system for pharmaceutical manufacturers whose products are sold commercially He has to collect and evaluate reports on drug risks and coordinate any necessary actions, and even more. To do this, the QPPV must be available 24/7, 365 days a year. Diapharm is the perfect partner for pharmaceutical companies that wish to outsource this position.
We will help you by assuming the duties and responsibilities of:
- The qualified person for pharmacovigilance (QPPV) for the European Union
- The national QPPV / local safety officer in EU member states, in which local representatives are required, such as in
- Germany
(Stufenplanbeauftragter, acc. to Art. 63a AMG) - Spain
(Persona responsable de farmacovigilancia acc. to RD 1344/2007, sect. 9)
- Ensuring that regulations are complied to cost-effectively
-
Fulfilment of European and national requirements for pharmaceutical companies
- No commitment of personnel
- Guaranteed availability as required
