Setting up a pharmacovigilance system and creating the necessary risk management plans and SOPs can tie up a lot of capacity in pharmaceutical companies. However, the description of the QMS and the measures taken for drug safety – the so-called Pharmacovigilance System Master File (PSMF) in accordance with Directive 2010/84/EU – is essential for drug approval. SwissPharmAudit® offers solutions to make pharmacovigilance in companies simpler and still safe. We help review internal drug safety procedures, formulate SOPs and provide appropriate risk management plans and complete pharmacovigilance systems where required.
The person responsible for the overview of the benefit-risk profile of medicinal products marketed in the EU is the Qualified Person for Pharmacovigilance (QPPV) or, in Germany, the Graduated Plan Officer. The QPPV is the direct contact for authorities when it comes to the safety of medicines and must be based in the EU.
The QPPV essentially fulfills three key tasks:
- the implementation, optimization and maintenance of the pharmacovigilance system
- the overview of the risk-benefit profile of all authorized medicinal products
- contact person for approval authorities (24 hours a day) and for inspections.
We are at your side as a qualified, experienced and regularly trained QPPV and Deputy QPPV. In Germany, we also offer you our service as an external graduated plan officer according to AMG.
We would be happy to support and advise you in the context of clinical research in setting up, optimizing and maintaining your PV quality management system.