Each holder of a manufacturing authorisation of medicinal products in Europe needs to name at least one Qualified Person (QP). The legal basis for the appointment of a QP is defined in the DIRECTIVE 2001/83/ relating to human medicinal products and in DIRECTIVE 2001/82/EC relating to veterinary medicinal products. These Directives clearly determine the educational background and professional experience a professional needs to have to act as a QP as well as the duties and responsibilities associated with this function.
The European QP Association represents QPs in the European Union. We support QPs e.g.
by providing a platform for the exchange of experience
by discussing the latest regulatory requirements,
by addressing difficulties and challenges and
by supporting a harmonised European approach.
Each Qualified Person can become member of the European QP Association at no costs. As an interest group of the ECA Foundation the Association is supported by the Foundation in fulfilling their tasks. Please learn more about us here
Image taken at the QP Forum 2014 in Vienna, Austria
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Qualified Person Forum 2015 This Conference is designed by QPs for QPs as an international Expert Forum with focus on sharing information and experience and on discussing the critical areas of the QP’s daily work.