European initiative towards quality standards in education and training for discovery, development and use of medicines

Heinrich Klech, Cath Brooksbank, Shirley Price, Patrice Verpillat, Fritz R Bühler, Dominique Dubois, Norbert Haider, Claire Johnson, Hans H Lindén, Tony Payton, Oliver Renn, Wolf See
European Journal of Pharmaceutical Sciences 2012 April 11, 45 (5): 515-20
This position paper recommends a set of standards for quality assessment of continuing professional development (CPD) for medicines research and development (R&D). We have developed these standards to help us achieve the education and training goals of the Innovative Medicines Initiative (IMI;, which is developing courses to address the skills gaps in European medicines R&D. The IMI shared standard for course quality will enable professionals in medicines R&D to create a personalized portfolio of education and training that best suits their needs. Individuals already working in the pharmaceutical industry will be able to select modules for study on an as-needs basis, which may be combined to gain a qualification that is recognized throughout Europe. By seeking input from the medicines R&D community, especially professional bodies involved in the career development of biomedical scientists, we hope to initiate the creation of a mutually recognized framework for lifelong learning in medicines R&D. The shared standards call for defined and transparent admission criteria, a predefined set of teaching objectives leading to defined learning outcomes, assessment of the students' achievement, a system for collecting, assessing and addressing feedback, and provision of appropriate and updated reference material. This framework will make it easier for professionals to develop the skills required by industry, and easier for employers to recognize professionals with appropriate skills. It will obviate some of the need for retraining personnel who have already developed appropriate skills in a different setting, thereby saving the industry additional effort. Fulfilment of quality standards by course providers will be made transparent within the IMI's catalogue of courses, on-course (, which will be made publicly available during 2012.

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