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
Achievements & News
IMI’s PharmaTrain project provided much needed harmonisation and coordination among European universities offering medicines development education and training. In an interview with the IMI Programme Office, former project coordinator Ingrid Klingmann, now president of the successor organisation, PharmaTrain Federation asbl, and Matthias Gottwald of Bayer, explain why this was an important opportunity, and why universities around the world are envious that Europe could make such a project happen. ### ‘This was a unique opportunity for all these course providers to come out of their ivory towers, jointly analyse the deficiencies and figure out how to do it together in the best way,’ said Klingmann. ‘It was a once-in-a-lifetime chance to make this happen.’ Read the full interview
IMI education and training project IMI-TRAIN is working to address the competencies (i.e. the skills, knowledge and behaviours) needed by people working in safety sciences for medicines and devices. Now, the project has set up a specially-created task force to set out the competencies needed in a range of academic, industry and regulatory settings regarding safety sciences. Examples of competencies identified so far include:###
- access, integrate and critically analyse data from multiple sources to help answer drug safety questions;
- define and implement safety analysis strategies;
- demonstrate high-level knowledge of global regulations with respect to drug safety and adverse event reporting, and the development, implementation and monitoring of risk management activities.
- evaluate safety data to assess benefit versus risk to individual patients, research subjects, and/or to a given population and its environment.
The task force is now gathering input from experts in academia, industry and regulatory authorities with regards to the competencies for those working in the area of safety sciences. The project hopes that the outcomes will help professionals, employers and those providing education in this area to assess the courses to ensure that the needs of all the stakeholders are met. The various courses and programmes currently on offer are aligned with what the sector requires. More broadly, the competencies, along with an accreditation system, will help to recognise and consolidate the expertise gained from attending the safety science’s courses. This will, going forward, contribute towards a certified profession of safety scientists.
PharmaTrain has teamed up with the International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical medicine (IFAPP) and the Società de Scienze Farmacologiche Applicate (SSFA) to organise a joint event in Rome, Italy on 10-11 June 2015.###
The event, ‘Advancing competent professionals in medicines development’, will present the results of the IMI project PharmaTrain. Over the past five years, Pharmatrain has put together a new concept for education in pharmaceutical medicine. Another highlight of the event will be the presentation of a complementary and new personal development programme which will lead to the title of SMD – ‘Specialist in Medicines Development’. The SMD project, a global initiative, will be soon implemented in Italy, Japan and in many more countries.
April saw the launch of the imi-train website. imi-train is a new joint European platform that provides education and training solutions in the medical, biomedical and pharmaceutical sciences.### Established by the IMI Education and Training projects EMTRAIN, Eu2P, PharmaTrain and SafeSciMET, imi-train is set to become the most broadly recognised point of reference for scientists who seek guidance for their continuing professional development. Visitors to the website, such as course providers, professional bodies, employers and individuals, can browse academic postgraduate programmes and short courses, benefit from career development services and find information and access to course portals, quality standards, accreditation and e-learning possibilities.
The aim of the course is to train experts who understand the complex process of medicines development from molecule to healthcare and who can apply this knowledge working in large or small companies, regulatory agencies, in health care and health insurance management. The course consists of a basic course of six modules which provide a complete overview of all drug development related topics listed in the Pharmatrain Syllabus. Combined with six further advanced elective modules and followed by a thesis based on scientific work, students will work towards a Masters-level degree in Medicines Development.
The course material was carefully compiled by academic and industry experts to meet the needs of both the pharmaceutical industry and health care and covers three main areas: drug development and clinical trials; regulatory affairs and safety of medicines; health care and professionalism. The joint course is offered by 10 cooperating regional universities and is coordinated by the Semmelweis University, Budapest, Hungary.
- The course will begin in the first half of 2015
- Deadline for applications: 31 January 2015
- Further information about the course is available on the CEMDC website
IMI’s Education and Training project PharmaTrain and the Alliance for Clinical Research Excellence and Safety (ACRES), an international not-for-profit organisation for setting global clinical trial site standards (including improving education and training of professionals in medicines development), have joined forces in a Strategic Alliance.### The goal is to promote the adoption of new and reliable global standards for high-quality postgraduate education and training for individuals pursuing careers in the discovery, development, regulation and marketing of new medicines.
Proposed projects within the framework of the Strategic Alliance include the development and dissemination of curriculum standards for educational programs and the implementation of a global quality assessment and recognition process for educational programmes and training courses as part of the shared infrastructure necessary for the multi-stakeholder integration of education in medicines development.
PharmaTrain has developed a rigorous approach to standards-based education and training achieved through the creation of a Syllabus of Medicines Development, which is aligned with the core competencies for scientists involved in medicines development. This approach will be disseminated and implemented worldwide through the alliance with ACRES. ‘Currently over 30 leading universities in Europe and North America have implemented the PharmaTrain curriculum - with ACRES, our new strategic partner, we intend to offer PharmaTrain to the world', comments PharmaTrain coordinator Dr Ingrid Klingmann of the European Forum on Good Clinical Practice (EFGCP).
- Read the full press release
IMI’s Education and Training project PharmaTrain has recently added two universities to its Centres of Excellence network. The addition of Cardiff University and the Catholic University Medical School of Rome to the network brings the number of PharmaTrain Centres of Excellence to 11.### Both universities are part of the PharmaTrain Global 45 Universities Network.
The programme within PharmaTrain’s framework at the Cardiff University is a Postgraduate Course in Pharmaceutical Medicine. ‘Excellent course content, experienced presenters and interaction with my colleagues from different medical specialties added immensely to my on-the-job training! […]. The Cardiff course equipped me with many ideas, which I will implement in my daily job,’ comments Dr Victoria Zazulina of Boehringer Ingelheim, UK.
The Catholic University of Rome offers a Master in Preclinical and Clinical Research and Development of Drugs. ‘The Course helped me to have a comprehensive look at different areas of clinical research. […] It has been an extremely rewarding experience, which I think will be an asset for my future career path,’ explains student Chiara Mozzetta.
- Learn more about PharmaTrain’s upcoming courses
IMI project PharmaTrain has successfully launched the Cooperative European Medicines Development Course (CEMDC), a postgraduate qualification in medicines development.### At a ceremony in Budapest, Hungary on 30 October, high-level representatives of 10 universities signed a Memorandum of Understanding formalising the cooperation, which will allow students to take modules offered jointly by the partner universities. Degrees will be formally awarded by Budapest’s Semmelweis University on behalf of the partner universities. The CEMDC was set up by PharmaTrain to provide a university network that could provide pharmaceutical medicine training in countries where no such education was established. The universities involved in the CEMDC are located in Estonia, Hungary, Lithuania, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, and Turkey. The initiative therefore gives students from the central and Eastern European and Mediterranean regions the opportunity to benefit from the very best teaching offered jointly by all participating universities. The university network concept was developed because in small countries and countries with small pharmaceutical industries, only a network concept can guarantee long-lasting sustainability of the programme. The course will start in April 2013. ‘This is a quite unique cooperation which could only be organised within the IMI programme and with the active support of the PharmaTrain cooperation,’ commented CEMDC Study Director Sandor Kerpel-Fronius of Semmelweis University.
IMI Education and Training project PharmaTrain is extending its global reach by signing Memoranda of Understanding (MoUs) with universities around the world.### ‘Affiliated institutions benefit from the Quality Standards of IMI PharmaTrain and share the interest to find a common process to train medicines development for integrated drug developers and to foster continuing professional development,’ explains PharmaTrain coordinator Fritz Bühler of the University of Basel. The move also allows PharmaTrain to benefit from non-European expertise in medicines training, and also highlights Europe’s leading role in this area. The universities of California and Peking were the first to sign MoUs with PharmaTrain, and the project is in discussions with a number of other institutions. ‘Eventually, one global training concept for medicines development and regulation will emerge which greatly facilitates global medicines development,’ comments Professor Bühler.
Hibernia College Dublin in Ireland has been named as the first PharmaTrain Centre of Excellence. The college, 1 of 14 training providing partners in the IMI Education & Training project PharmaTrain###, used the PharmaTrain Shared Standards to create a new online Master of Medicines Development programme. The announcement means that PharmaTrain is making great strides towards its goal of creating a pan-European, collaborative network for comprehensive post-graduate training. The modular courses devised by the partners allow students to mix and match to tailor their education to their own professional training needs. The project’s short and snappy ‘Career Driver’ newsletter provides regular updates on this successful project’s progress, along with lively quotes from both students and project partners. To sign up, visit the PharmaTrain website.
October 2010 - The programme includes Base courses and Master programmes taught at partner universities all across Europe. A full overview is available at www.pharmatrain.eu.### Another early achievement of the PharmaTrain project is the publication of a 2010 European Training Syllabus for Pharmaceutical Medicine on the PharmaTrain website . It summarises the learning content that will be addressed in the courses mentioned above. The syllabus has been internationally recognised and adopted by the International Federation of Associations of Pharmaceutical Physicians (IFAPP) and the Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians of the United Kingdom. In Spring 2011, the corresponding detailed learning outcomes will be published in the 'PharmaTrain Programme Handbook. Shared Curriculum and best practices'.
Cooperative European Medicines Development Course – registration open!
July 2015 - Registration is now open for the third edition of the Cooperative European Medicines Development Course (CEMDC) course which will kick off in September this year. The course, which was designed under the IMI project PharmaTrain, aims to educate experts in the process of medicines development ###and train them to apply this knowledge in large or small, innovative or generic pharmaceutical companies, regulatory agencies, healthcare and health research or insurance management. The course material was carefully compiled by academic and industry experts to meet the needs of both the pharmaceutical industry and health care and covers the following areas:
- drug development and clinical trials;
- regulatory affairs and safety of medicines;
- life cycle management and medical marketing of medicines;
- healthcare and professionalism.
The teaching follows the international, harmonized modular training programme and quality standards developed by PharmaTrain. The CEMDC is Coordinated by the Semmelweis University in Hungary and is accredited as a PharmaTrain Center of Excellence. The Diploma Course contains 8 modules, and students can opt to follow selected modules only or the entire course.
- Deadline for registration: 31 August 2015
- Details of how to register can be found on the CEMDC website
Meet the IMI Education and Training Programmes
December 2013 - There are five projects within IMI’s research training platform aiming to revolutionise education and training to deliver more effective and safe new medicines for patients – EMTRAIN, Eu2P, EUPATI, PharmaTrain, and SafeSciMET. Collaboration is the key to ###success and equally important is the projects' ability to reach intended audiences with information to raise awareness and encourage people to get involved in project activities.
Over the next six months these projects will be represented at a variety of European and international conferences through display booths, dedicated sessions or individual presentations. If you are planning to attend any of the following events, please take the opportunity to stop by and find out what is happening in the IMI training and education programmes and how you can benefit, either from a professional or personal perspective.
- DIA EuroMeeting 2014 (Vienna, 25-27 March)
- EUPATI Regional Meeting 2014 (Warsaw, 2-3 April)
- World Research and Innovation Congress (Amsterdam, 5-6 June)
- Euroscience Open Forum (Copenhagen, 21-26 June)
BIOVISION and the IMI Education & Training projects
February 2013 - IMI and the IMI Education & Training projects participated in BIOVISION - the World Life Sciences Forum, which was held in Lyon, France, on March 24-26 2013. It is the place where key stakeholders ###debate the impact of the latest scientific advances on society and share their vision on how to overcome health, environment and nutrition challenges. IMI Executive Director Michel Goldman participated in the plenary session ‘How to make better use of collective intelligence’. Mike Hardman, project coordinator of EMTRAIN, represented IMI and the IMI E&T projects in the BIOVISION Investor Conference workshop. Moreover, the IMI E&T projects organised a satellite event on ‘Training and Education in Europe’ where they presented their activities to the forum’s participants at a booth in the exhibition area.
IMI Education & Training projects in the spotlight at DIA EuroMeeting 2013
February 2013 - This year’s DIA EuroMeeting, which was held in Amsterdam, the Netherlands from 4 to 6 March, featured an entire theme dedicated to IMI’s five Education & Training (E&T) projects. The sessions featured ###the latest news from the projects and demonstrated how they are helping to advance education in the biomedical sector in Europe. DIA EuroMeeting visitors could also catch up with the projects and find out how IMI’s E&T projects can boost their careers.
- View the agenda for the IMI theme in the DIA EuroMeeting programme(page 46)
Check out the IMI Education & Training projects’ video
November 2012 - Four of IMI’s Education & Training projects have put together a short video on their activities.###In the six-minute clip, the coordinators of the EMTRAIN, SafeSciMET, Eu2P, and PharmaTrain projects present their courses and the benefits they offer for students and course providers alike. The film also features a presentation by IMI Executive Director Michel Goldman.
ParticipantsShow participants on map
- Almirall SA, Barcelona, Spain
- Amgen, Brussels, Belgium
- Astrazeneca AB, Södertälje, Sweden
- Bayer Pharma AG, Berlin, Germany
- Esteve Pharmaceuticals, SA, Barcelona, Spain
- F. Hoffmann-La Roche AG, Basel, Switzerland
- Glaxosmithkline Research And Development LTD., Brentford, Middlesex, United Kingdom
- Janssen Pharmaceutica Nv, Beerse, Belgium
- Merck Kommanditgesellschaft Auf Aktien, Darmstadt, Germany
- Novartis Pharma AG, Basel, Switzerland
- Novo Nordisk A/S, Bagsvaerd, Denmark
- Orion Oyj, Espoo, Finland
- Pfizer Limited, Sandwich, Kent , United Kingdom
- Sanofi-Aventis Recherche & Developpement, Chilly Mazarin, France
- UCB Pharma SA, Brussels, Belgium
Universities, research organisations, public bodies, non-profit groups
- Cardiff University, Cardiff, United Kingdom
- DIA Europe GmbH, Basel, Switzerland
- European Federation For Pharmaceutical Sciences, Järfälla, Stockholm, Sweden
- European Forum For Good Clinical Practice, Brussels, Belgium
- European Organisation For Research And Treatment Of Cancer Aisbl, Brussels, Belgium
- Faculty Of Medicine, University Of Belgrade, Belgrade, Serbia
- Fondation Health Sciences e-Training, Lausanne, Switzerland
- Goeteborgs Universitet, Gothenburg, Sweden
- Hibernia College, Dublin, Ireland
- International Federation of Associations of Pharmaceutical Physicians, Woerden, Netherlands
- Karolinska University Hospital, Stockholm, Sweden
- King'S College London, London, United Kingdom
- Kobenhavns Universitet, Copenhagen, Denmark
- PHARMED asbi, Brussels, Belgium
- PME Institute for Education in Pharmaceutical Medicine, Witten, Germany
- PharmaTrain Federation, Basel, Switzerland
- Semmelweis Egyetem, Budapest, Hungary
- Stichting Lygature, Utrecht, Netherlands
- Swissmedic, Berne, Switzerland
- The Faculty Of Pharmaceutical Medicine Of The Royal Colleges Of Physicians Of The United Kingdom Lbg, London, United Kingdom
- Trinity College Dublin, Dublin, Ireland
- Universidad Pompeu Fabra, Barcelona, Spain
- Universita Cattolica Del Sacro Cuore, Milan, Italy
- Universitaetsklinikum Essen, Essen, Germany
- Universitaetsklinikum Freiburg, Freiburg, Germany
- Universitat Autonoma De Barcelona, Bellaterra, Spain
- Universitat Basel, Basel, Switzerland
- Universitat De Barcelona, Barcelona, Spain
- Universitat Wien, Vienna, Austria
- Universite Louis Pasteur, Strasbourg, France
- Universite Lyon 1 Claude Bernard, Villeurbanne, France
- University Of Newcastle Upon Tyne, Newcastle upon Tyne, United Kingdom
- University Of Surrey, Guildford, United Kingdom
Non EFPIA companies
- Medicines and Healthcare products Regulatory Agency, London, United Kingdom
|Name||EU funding in €|
|Cardiff University||50 000|
|DIA Europe GmbH||18 333|
|European Federation For Pharmaceutical Sciences||41 666|
|European Forum For Good Clinical Practice||133 233|
|European Organisation For Research And Treatment Of Cancer Aisbl||23 333|
|Faculty Of Medicine, University Of Belgrade||23 000|
|Fondation Health Sciences e-Training||68 333|
|Hibernia College||124 333|
|International Federation of Associations of Pharmaceutical Physicians||360 000|
|Karolinska University Hospital||2 780|
|King'S College London||42 220|
|Kobenhavns Universitet||18 333|
|Medicines and Healthcare products Regulatory Agency||18 333|
|PharmaTrain Federation||290 000|
|PHARMED asbi||213 834|
|PME Institute for Education in Pharmaceutical Medicine||15 333|
|Semmelweis Egyetem||314 800|
|The Faculty Of Pharmaceutical Medicine Of The Royal Colleges Of Physicians Of The United Kingdom Lbg||195 000|
|Trinity College Dublin||35 000|
|Universidad Pompeu Fabra||18 333|
|Universita Cattolica Del Sacro Cuore||13 333|
|Universitaetsklinikum Essen||13 333|
|Universitaetsklinikum Freiburg||13 333|
|Universitat Autonoma De Barcelona||18 333|
|Universitat Basel||1 063 285|
|Universitat De Barcelona||38 333|
|Universitat Wien||38 333|
|Universite Louis Pasteur||13 333|
|Universite Lyon 1 Claude Bernard||205 000|
|University Of Newcastle Upon Tyne||6 333|
|University Of Surrey||10 888|
|Vienna School Of Clinical Research Verein (left the project)||56 933|
|Total Cost||3 510 300|