Europe needs experts in the pharmaceutical industry who are able to oversee the entire medicines development process, from the identification of a molecule, through pre-clinical and clinical trials, all the way to the regulatory process and market approval. Yet education and training in these fields has been quite fragmented in Europe. The aim of PharmaTrain was to bring together all the experts who are teaching this subject and make them agree on the content that should be taught when someone wants to become a specialist in these areas. The project also wanted to ensure that post-graduate training courses that are offered across Europe have the same quality, delivering the same type of learning effect, no matter where the training is carried out.
By bringing together 20 university training programmes, 10 learned societies, 3 competent authorities, several partner training organisations and 15 pharmaceutical companies, PharmaTrain managed to achieve all its objectives. One of its main achievements was to create common standards and guidelines for universities who want to develop training in medicines development, regulatory affairs, clinical trials, investigator training and clinical trial management. The partners also developed a set of criteria which can be used to recognise and assess the quality of available courses in these fields, along with labels which can be awarded to programmes which meet the required standards. Thanks to this system, the project developed a network of 13 courses which are now recognised as Centres of Excellence, and evaluated more than 150 short courses.
More specifically, the project delivered the following outputs:
- a syllabus and curricula for medicines development;
- a concept for professional certification in medicines development, which has already been implemented in Italy and Japan as a pilot;
- a joint postgraduate course in medicines development, which is offered by 10 cooperating regional universities, mostly in eastern Europe;
- syllabus and learning outcomes for 26 elective modules in medicines development;
- 9 e-learning compact modules which are freely available;
- a good examination practice guide;
- a concept for a post-graduate, on-the-job certification programme leading to a ’specialist in medicines development’;
- a syllabus and curriculum for a postgraduate master of regulatory affairs;
- a clinical investigator training concept.
For the benefit of industry, academia and patients
For the academic community, this project represented a unique opportunity to come together, join forces and agree on shared quality standards for training in medicines development, regulatory affairs and investigator training. It was also an opportunity to adapt their courses to the needs of the industry.
The industry benefited by getting employees who have a more integrated view of the needs in research and development and can be more easily integrated into companies. They have also benefitted from the network which was established during the project.
Ultimately, it will be the patients who will benefit, as the new, higher quality training standards will result in better trained medicines development professionals, which in turn will lead to better and safer medicines for patients.
After the end of the project, all the partners have agreed to donate project outcomes to the new PharmaTrain Federation, a non-profit organisation which was established to continue some of the project’s work. The federation is self-sustaining through membership fees, and among other things, it continues to asses courses offered in the medicines development field. It provides ‘PharmaTrain Recognition’ for individual courses and ‘Centre of Excellence Recognition’ for academic, commercial and non-commercial training organisations fulfilling the shared quality standards developed by the project.
Read the interview with project coordinators