Qualified Person Learning Programme Development: An Example of the Tempus Joint Project Activity

Abstract

The role of Qualified Person (QP) is a pivotal one in Quality Assurance within the pharmaceutical industry. The competences required are usually achieved through work experience and more formal forms of learning, such as postgraduate MSc and/or relevant short-term courses. Duties of QP in the pharmaceutical sector in Serbia used to be performed by expert pharmacists with the relevant industrial experience and a Postgraduate Specialization Degree in Drug Analysis and Quality Control. However, it has been recognized that the learning needs of QPs should be extended to include knowledge of drug formulation and manufacturing processes. Taking into account the pre-accession status of Serbia, harmonization with EU practice and policies has been emphasized. In particular, compliance with EU directives 2001/82/EC and 2001/83/EC, which detail the role of, and academic qualifications required by a QP will be necessary. In order to respond to this need which has been highlighted within the sector, the Faculty of Pharmacy, University of Belgrade took responsibility for establishing the relevant postgraduate course, and set this as one of the priorities of the current Tempus PQPharm Project. The aim of this work is to provide an example of an outcomes-based interactive approach to curriculum development performed through an international joint-project collaboration activity