The requirement profile for Qualified Persons (QP) is defined in the European Directive 2001/83/EC. In the various EU member countries this guideline’s content is not implemented the same way, though. Many countries require a broad academic education which ultimately equals the studies of pharmaceutics. Graduates from other (natural science) studies can theoretically become QP in the area of medicinal products as well – if they cover subjects at an appropriate university they did not cover during studies before. This is currently a huge problem because a lot of member states do not offer an adequate academic training by standard (as e.g. in Germany), and those that were passed, are more or less the result of hard work from private initiatives.
Another obstacle for the recognition as QP is the required fulfilment of two years practical experience which needs to be gained in the qualitative and quantitative analysis of medicinal products in with a company holding a marketing authorisation. This excludes many graduates who can not provide the necessary proof from their university, but also pharmacists who gained their practical experience rather in the manufacture of medicinal products than in the analysis. In both areas there are professionals, though, who would be absolutely eligible to assume a QP function.
The European QP Association (EQPA), the interest group of European QPs, has been already criticising this situation as well as the different interpretation of the Directive in the various Member States. Moreover, the German “Verband der forschenden Pharma-Unternehmen (VfA)” which is the German association of researching medicinal product manufacturers, just issued an according position paper. In the association’s view it is urgently necessary to review the existing regulations regarding the required proof of expertise for QPs to avoid that there is an increasingly smaller group of professionals who can assume QP functions. In this context the VfA requests a much more pragmatic interpretation of the requirements with regard to expertise and experience. The association also recommends to also acknowledge courses completed outside academic pharmaceutical studies.
The European QP Association (EQPA) welcomes the VfA’s position paper (in German language) and will fully support further planned activities of the association.
Dr. Bernd Renger
Chairman of the European QP Association
Source: Press release