PharmaTrain, an IMI Education & Training project, focused on improving speedy medicines development through better and comprehensive training programmes. Medicines development can only be successful when it is supported and guided by regulatory knowledge excellence.
Thus, Regulatory Affairs has become a specialty in itself, as is shown by setting up special university chair positions (e.g. at the Schools of Pharmacy of the Universities of Bonn and Hohenheim), and development of a number of trainings by Universities and professional course providers. These programmes and experience gained by trainees have demonstrated that Regulatory Affairs today encompasses a wide variety of regulatory areas like regulatory aspects in production and distribution, pre-marketing and post-marketing, as well as various types of inspections and good practices. Without proper knowledge of regulatory legislation and its implementation by guidelines and further detailed instructions, and working as an integral part of the development teams, medicines development will remain rather slow and below capacity of the therapeutic moiety under development.
Within PharmaTrain a group was established to develop a comprehensive Syllabus, Learning Outcomes and Curriculum for training for students, and guidance to universities running - or wishing to set-up - a postgraduate Regulatory Affairs Master Programme. All elements of this training programme were developed within the Task Force on Regulatory Affairs, and were supported by some thirty experts from pharmaceutical industry, regulatory authorities, universities, and CRO’s. They successfully developed the training programme, which now forms the basis for four European Universities. The Universities of Basel, Copenhagen, Hertfordshire, and King’s College London have agreed and signed an MoU towards offering in a harmonized way the necessary knowledge and competencies, either as single modules, or as a full “Master for European Regulatory Affairs. The concept foresees performance of the majority of modules, examination and master thesis at the “home” university but highly recommends taking individual modules at partner universities.
Details for harmonized implementation of the university programmes, which will be executed at Basel together with DIA Europe, at Copenhagen with Medicademy, and at Hertfordschire with TOPRA, are currently being developed under the leadership of Copenhagen’s Anne-Marie S. Clemensen (This email address is being protected from spambots. You need JavaScript enabled to view it.). Details about the programme can be obtained from Rolf Bass (This email address is being protected from spambots. You need JavaScript enabled to view it.).
A joint university announcement will be made public on 15 May 2014.
Berlin, 10 May 2014
Contact websites:
Universities:
King’s College London: www.kcl.ac.uk;
University of Basel, European Center of Pharmaceutical Medicine: www.ecpm.ch;
