BACKGROUND OF THE CEMDC CONCEPT
Cooperative European Medicines Development Course (CEMDC)
European Innovative Medicines Initiative (IMI; http://www.imi.europa.eu)
Pharmaceutical Medicine Training Program (PharmaTrain; PhT; www.pharmatrain.eu)
Study Director: Prof. Sándor Kerpel-Fronius, M.D., D.Sc.
The idea of the CEMDC was born and realized in the IMI-PharmaTrain program:
Working Project 5: Geographical Extension of Training Sites and Network
Project Academic Leader: Prof. Dr. Sandor Kerrpel-Fronius, Department of Pharmacology and Pharmacotherapy, Semmelweis University, Budapest, Hungary
Project Industrial Co-Leader: Dr. Matthias Gottwald, Vice President Research Policy and Collaborations, Bayer Healthcare Pharmaceuticals, Bayer Pharma AG, Berlin, Germany
As part of the above EU-IMI program initiated with the aim to increase the competitiveness of the European Pharmaceutical Industry, a working contact was established with several universities working in the Central East European Region in 2009 for organizing a joint, post-graduate international medicines development teaching course. The suggested cooperative course will be part of the European Curricula for Global Expertise in medicines development. It will use the harmonized European educational, examination and quality assurance programs which has been developed by the IMI-PharmaTrain cooperation involving the major European course providing universities. Only students with finished primary university education in medicine, pharmacy or life sciences and who have at least one year of working experience in drug development and/or regulation will be enrolled. The outcome will be experts who have a comprehensive understanding of the entire drug development process including discovery, non-clinical and clinical developments, drug formulation, safety and regulatory requirements, pharmacoeconomics as well as marketing and promotion of medicines. Such experts are increasingly needed both for the globally and nationally active pharmaceutical industries and regulatory bodies.
This highly specialized, complex program can be offered cost-effectively for smaller nations and/or countries having a relatively small pharmaceutical industry only if the minimal 20 to 30 students per year necessary for maintaining the program are pooled together from several countries into a joint international course offered by several universities in cooperation. Similarly the internationally outstanding educational staff needed can be most efficiently selected from several participating universities and from a broad pool of national experts working in these countries. The added value of the course given jointly by several universities in English language is the multi-national certificate scientifically accredited by the PhT organization which is a guarantee of its broad international acceptance.
CEMDC is the member of the PharmaTrain Federation which continues the educational activities of the IMI-PharmaTrain project.
Governing of the CEMDC
CEMDC is a cooperative educational organization based on a multinational university consortium which has been established for post-graduate training in Drug Development Science (Medicines Development Science, Pharmaceutical Medicine) within the IMI-PhT program. The principles of the consortium and the obligations of the partners are defined in a Memorandum of Understanding (MOU) signed by all participating universities and in separate Cooperation Agreements signed bilaterally by Semmelweis University – the Coordinating University entrusted by IMI-PhT – and each Participating University.
The CEMDC is directed by a Governing Board (GOBO), in which each Participating University is represented by one local Program Coordinator appointed by that university. Each university has one vote. The Participating Universities will control and manage the CEMDC through their appointed representatives in the GOBO. Representatives of the European Federation of Pharmaceutical Industries and Associations (EFPIA), the European Generic Medicines Association (EGA) and the European Medicines Agency (EMA) might be invited, if needed, to participate and serve as counselors in the discussion, without any voting rights. The GOBO decides upon and supervises all educational, financial and administrative activities, centralized advertisements, makes principal decisions in these matters and, finally, evaluates the course performance. The tasks include planning the tuition and other fees, the educational program, the budget required for the organization of modules by the Participating Universities, determining the honoraria, required travel and accommodation support for the Lecturers and management team and, finally, the GOBO accepts the Standard Operating Procedures relevant to the various functions of the CEMDC. These activities are performed in accordance with the MOU and the respective regulations of the Coordinating University.
The GOBO must be convened once per year by the Study Director (See point 4.4), who also chairs the sessions. The GOBO has a quorum if at least 50% of the Coordinators are present. The decisions of the GOBO are based on the affirmative votes given by the majority of the university representatives present. If there is equality of votes, the proposal will be rejected. The Standard Operating Procedure of the CEMDC can be changed only with an over 80% majority vote of the Members.
Representatives of Universities participating in the negotiations for establishing the Cooperative European Medicines Development Course (CEMDC)
- Dr Alar Irs, University of Tartu, Estonia
- Dr Beatriz Silva Lima, University of Lisbon, Portugal
- Dr Emese Sipos, Faculty of Pharmacy, University of Medicine and Pharmacy of Targu-Mures, Romania
- Dr Irena Mlineric-Rascan, University ofLjubljana, Slovenia
- Dr Jan Klimas, Faculty of Pharmacy, Comenius University, Bratislava, Slovakia
- Dr Mattias Gottwald, Co-Chairman of the Pharmatrain Geographical Extension Project, Bayer Health Care, Bayer Schering Pharma, Berlin, Germany
- Dr Milicia Prostran, University of Belgrade, Republic of Serbia
- Dr Romaldas Maciulaitis, Medical University, Kaunas, Lithuania
- Dr Sandor Kerpel-Fronius, M.D., D.Sc., Chairman of the Pharmatrain Geographical Extension Project, Semmelweis University, Budapest, Hungary
- Dr Zafer Guney, Department of Pharmacology, Gazi University, Medical Faculty, Ankara, Turkey
- Dr Zbigniew Gaciong, Medical University of Warsaw, Poland
Inauguration Ceremony of the Cooperative European Medicines Course
First-of-its-kind regional multinational postgraduate course organised in medicines development
The Cooperative European Medicines Development Course (CEMDC) was officially inaugurated at a ceremony held at Semmelweis University on October 30, 2012. Based on a multinational interuniversity cooperation, the CEMDC aims to provide high quality education in countries where, due to small population size and a relatively minor pharmaceutical industry, the long-term operation of such a specialised programme would be unfeasible without collaboration. A truly European initiative, the ten participating universities are located in ten different nations across Central, Eastern and Southern Europe.
The CEMDC is supported by the European Union’s Innovative Medicine Initiative (IMI), the largest public-private partnership in Europe aimed at increasing the continent’s competitiveness in the pharmaceutical industry. Ann Martin, Principal Scientific Manager of the IMI, explained that the main reason why the organisation decided to fund the CEMDC initiative was that the project fit in very well with their European mission: “We are looking at bottlenecks within the pharmaceutical industry and trying to match that up with public partners; here, we have an ideal situation where we will end up with a course that addresses this bottleneck in the industry.”
The preparatory work, which commenced in 2009, was carried out within the Geographical Extension working group of the IMI-funded PharmaTrain project. “It was a long time of discussions and planning, but good planning is necessary to launch any programme in a successful way,” Dr. Fritz Bühl, Coordinator of PharmaTrain from the University of Basel related, adding that two of the keys to its success were the project’s academic leader and industrial co-leader, Prof. Sándor Kerpel-Fronius (Department of Pharmacology and Pharmacology, Semmelweis University) and Dr. Matthias Gottwald (Vice-President Research Policy and Collaborations, Bayer Healthcare Pharmaceuticals). “This is a complex undertaking and requires a lot of people, so you really need drivers,” he said.
The CEMDC is a unique interuniversity postgraduate course, with each of the participating universities having the opportunity to host individual modules. Students taking part in the training are placed into a unified international group, taught by an equally diverse group of instructors. Lecturers may come from either the partner universities or the pharmaceutical industry, thus allowing the CEMDC to choose from a wide array of international experts.
Project Academic Leader Sándor Kerpel-Fronius, from whom the original idea for the CEMDC came, sees the regional nature of the course as one of its biggest advantages, with the potential to benefit all nations involved. “In addition to teaching a harmonised curriculum applicable everywhere, we can focus on local developmental problems and the industrial and marketing background specific to the area, and perhaps suggest solutions to the students participating in the course.”
Looking beyond the region, Dr. Matthias Gottwald, the project’s Industrial Co-Leader, speculated on the course’s potential impact on the education of employees within the pharmaceutical industry, adding that the CEMDC could serve as “a role model for the ideas behind Bologna, for fostering mobility and creating a joint education landscape all across Europe.”
Looking back, one of the most rewarding aspects of the project for Prof. Kerpel-Fronius was seeing the various participants becoming a true team. “Slowly, slowly, the people sitting at the meetings began communicating in a much more relaxed way and became very close friends: a community has been created. I think this is the best thing we can see in today’s society. Of course, sometimes we have a very heavy discussion, but usually, at the end, we are all pleased.”
photo by attekovacs.com
Inauguration Lecture by Prof. Dr. Maria Judit Molnar Vice Rector of the Semmelweis University
The Class of the 2010 who attended the CEMDC Course finished their education and received their diploma
A comments of a graduate Dr Kata Mazalin
On the 10th October 2013 the absolvents of the first class of the postgraduate course on Medicines Development received their diplomas at the Semmelweis University. The students were of different educational and professional background and have been all working in different areas of medicines development for years. After the certificates have been handed over ceremonial by the dean, Dr. László Hunyadi, the students have been asked about their experience with the course and how they believe they have benefited from the participation.
The main opinion was that the course gave a broad overview about the life cycle of a medicine during and after development and helped so to understand the whole process and a prospect into the areas where one is not working on a daily basis. This can be helpful when planning complex operations and programs and to understand the tasks and importance of the other phases.
The students also pointed out the great value of the networking possibilities with the other participants and to be part of an „exclusive” group pioneering a novel educational model. Another added benefit was that the language of the course was English and it enhanced the language skills of the attendees.
Although some participants already reported to get ahead the diploma will hopefully help to further developments in their career path.
CEMDC Coordinating Office
Department of Pharmacology and Pharmacotherapy
Nagyvárad tér 4. Budapest H-1089, Hungary
Prof. Dr. Sandor Kerpel-Fronius
Ms. Judit Lendvay
DESIGN OF THE CEMDC WEBSITE
The various parts of the website contain information for selected groups of users some of which might be accessed only by specific username and password provided for the expected users.
Open for everyone.
This section contains general information on the CEMDC.
Open for everyone.
In this section administrative and scientific information concerning the program of ongoing or planned courses and/or individual modules to be presented at given dates are collected.
Open only for lecturers and Governing Board members of ongoing or planned courses and/or individual modules.
The overall aim of this section is to provide a joint discussion platform for the teachers. It should be used primarily for planning the detailed program, for selecting the materials to be presented and discussed, for the preparation of the examination and finally for the general evaluation of the overall teaching performance and educational results with the participation of all the lecturers in a cooperative manner. It is expected to become a well-used forum for exchanging ideas between lecturers of the CEMDC cooperation, for writing comments concerning the planned and delivered programs.
Open for everyone.
CEMDC is member of the PharmaTrain. The purpose of this section is to continuously inform both the teachers and students of the CEMDC on the working principles, resolutions and activities of the PharmaTrain cooperation as well as to provide links to the ongoing teaching programs offered by the various PharmaTrain course providers.
Open only for the official representatives of the participating universities and invited advisors.
This section will be used for presenting and discussing administrative, financial and quality assurance matters of the CEMDC cooperation.
Open for the present and past students of the CEMDC courses. Additionally access will be given for the university representatives and lecturers. This section will be subdivided for the students participating in the specified courses and will be accessible by individual usernames and passwords
The students might obtain academic and administrative information and news concerning their particular course, the list of materials to be studied in preparation for a module and the assignments to be written, the slides of the lectures, the cases discussed and finally the notes received. In addition it will contain a joint discussion platform for the enrolled students and also for alumni of earlier courses. It is expected to become a well-used forum for exchanging ideas between students and lecturers of the CEMDC courses.