THE Eu2P PARTNERS
The Eu2P training partnership is composed of seven Universities, the European Medicines Agency, the French Medicines Agency and fifteen Pharmaceutical Companies from the European Federation Pharmaceutical Industries Association (EFPIA).
The Université Bordeaux Segalen is the coordinating institution for the whole Eu2P programme that includes a Master, Certificates and a PhD in Pharmacovigilance and Pharmacoepidemiology.
As higher education institutions, Eu2P academic partners implement all education aspects.
- They define, provide and update skilled training contents at the introductory, intermediate and advanced levels
- They ensure that the training content meets major theoretical needs
- They transfer and evaluate knowledge and skills
- They offer placement possibilities to perform a research project
- They jointly award Eu2P diplomas
Université Bordeaux Segalen [coordinating institution]
The Université Bordeaux Segalen is the Health and Life Sciences University of Bordeaux (19,000 students - 1,000 faculty members). It is linked to the Bordeaux Teaching Hospital (3,800 beds).
Université Bordeaux Segalen hosts the Department of Pharmacology (over 100 members of staff) directed by Prof. Nicholas Moore.
The Department of Pharmacology is composed of six different specialised units among which are a clinical pharmacology unit, a regional pharmacovigilance centre and a pharmacoepidemiology unit. The Department of Pharmacology conducts large field studies of medicines utilisation, safety and performance, the results of which contribute to recommendations for optimising benefits and minimizing risks of medicines. It is also part of the French pharmacoepidemiology research network: the Inserm U657 'Pharmacoepidemiology and real-life impact of drugs' directed by Prof. Bernard Bégaud.
The Department of Pharmacology is coordinating the Master and the postgraduate diploma programmes in Pharmacoepidemiology and Pharmacovigilance. The national Master has been developed and coordinated by Dr Annie Fourrier-Réglat since 2004 in the interest of industry, regulatory and academic authorities.
Erasmus Universitair Medisch Centrum
Erasmus Universitair Medisch Centrum is the second largest university medical centre in the Netherlands for research, education and patient care (10,000 members of staff - 1,320 beds)
Erasmus Universitair Medisch Centrum includes Medical Informatics, an interdisciplinary research group, studying new methods for acquiring, representing, processing, and managing knowledge and data within health care and the biomedical sciences.
Its research clusters around two main themes: structuring of medical data, with the electronic patient record as an important application area, and structuring of medical knowledge, with decision support as main focus.
Erasmus Universitair Medisch Centrum is coordinator of European projects such as Eu-ADR about the safety signal generation in health records of 30 millions patients around Europe and SOS about the safety of non steroidal anti-inflammatory drugs both dealing with health care database linkage throughout Europe.
Erasmus Universitair Medisch Centrum is working closely together with the Dutch National Institute for Public Health and the Environment, called RIVM, to evaluate vaccine safety, with the PHARMO Institute to link data in the Netherlands and with the Dutch Medicines Evaluation Agency to tutor evaluators and provide expert opinion in the area of pharmacovigilance.
Erasmus Universitair Medisch Centrum is also involved in the Netherlands Institute for Health Sciences (NIHES), which is an international centre for postgraduate research and training in the disciplines of epidemiology, clinical epidemiology, health services research, public health, and medical informatics. NIHES prepares students for an international career as researcher, executive or advisor in clinical medicine, drug research, public health and health policy development.
Fundació Institut Catalá de Farmacologia - Universitat Autonoma de Barcelona
The Fundació Institut Català de Farmacologia is a non-profit institution founded in 1984.
It is a World Health Organization Collaborating Centre for Research and Training in Pharmacoepidemiology.
The Fundació Institut Català de Farmacologia is directed by Prof. Joan-Ramon Laporte and is part of the Autonomous University of Barcelona.
This institute aims at promoting the rational use of medicines and other therapeutic resources through various activities (case-control studies, case-population studies, voluntary reporting systems, medicines utilization studies, meta-analysis and benefit-risk evaluation).
The Fundació Institut Català de Farmacologia has developed a postgraduate training programme since 1991 that includes a biennial Master's Course in Pharmacoepidemiology (online since 2003), and the Doctorate in Pharmacology of the Autonomous University of Barcelona.
A total of 131 graduates from 16 countries have obtained a Master degree in Pharmacoepidemiology.
The institute also develops continuing education activities for primary health care professionals in Catalonia and in other autonomous communities in Spain.
University of Hertfordshire
The University of Hertfordshire is a research university (3,400 students and 2,700 members of staff) that is composed of 15 academic schools and 3 interdisciplinary research institutes.
The University of Hertfordshire hosts The Health and Human Sciences Research Institute whose main research areas include topical drug delivery, patient safety and pharmacovigilance, psychopharmacology and drug misuse.
Within its School of Life Sciences, the University provides a unique postgraduate programme in Pharmacovigilance with awards of postgraduate certificates, postgraduate diplomas and Master of Science. The Pharmacovigilance programme was established in 1998 in collaboration with the Pharmaceutical Information and Pharmacovigilance Association, and is tutored by Dr Sherael Webley. It offers postgraduate education and training in all areas of Pharmacovigilance including causality assessment, notifications systems, Eudravigilance and the Regulatory environment. In addition, it provides the opportunity for students to pursue a research project enabling them to study to Master level. The postgraduate certificates/diplomas programme is taught through teams of temporary part-time staff drawn from professions appropriate to pharmacovigilance and lecturers from the School of Life Sciences. This is a unique feature of the programme and is recognized as being of particular importance to the training of professional from both industry and regulatory agencies.
Universita di Verona
The Universita di Verona is a research university that includes 8 faculties and 15 research departments (23,000 students).
The Section of Pharmacology of the Public Health and Community Medicine Department includes the Clinical Pharmacology Unit, directed by Prof. Giampaolo Velo.
This Clinical Pharmacology Unit includes the Regional Pharmacovigilance Centre for Veneto Region, with a strict collaboration with the National Authority (Agenzia Italiana del Farmaco) in signal detection analysis, data mining in spontaneous reporting databases, terminologies (MedDRA) and risk communication.
The Unit is also involved in many pharmacoepidemiology studies, including the European project Eudragene on pharmacogenetics.
The Clinical Pharmacology Unit is a World Health Organization reference centre for education and communication within the programme for International Drug Monitoring, since 1997.
Within the The Universita di Verona, the unit provides the Master universitario di secondo livello in pharmacovigilance and regulations.
It organizes teaching courses on pharmacovigilance within the Continuous Education in Medicine for physicians and pharmacists in Italy.
The staff of the Unit is involved as teacher in other Italian Masters in Pharmacovigilance.
The Universiteit Utrecht is a research university comprising seven faculties, which collectively span the entire academic spectrum in teaching and research (30,000 students - 7,500 members of staff).
The Utrecht University hosts the Utrecht Institute for Pharmaceutical Sciences within its Department of Pharmaceutical Sciences.
In particular, this institute includes the Utrecht Pharmacoepidemiolgy Group that is one of the leading international academic groups for the interface between pharmacoepidemiology, pharmacovigilance and medicines innovation.
The Utrecht Pharmacoepidemiolgy Group has an extensive research record on new methods of data collection, study design and data analysis delivering more than 50 papers per year.
Key features in the profile of the group over the years have been new methods on drug channelling, exposure ascertainment, rare events, signal detection and evaluation, adjustment for confounding, record linkage, pharmacogenetics and implications for public health and weighing of benefit-risk.
This research group is an acknowledged World Health Organisation collaborating centre for Pharmacoepidemiology and Pharmaceutical Policy Analysis.
It also has close links to regulatory agencies such as the Dutch Drug Evaluation Board and the European Medicines Agency.
The Department of Pharmaceutical Sciences of Utrecht University participates in the Master Epidemiology Programme, which includes Master programmes in Clinical Epidemiology, Pharmacoepidemiology, Veterinary Epidemiology, Occupational and Environmental Epidemiology, and Infectious Disease Epidemiology.
For the organisation of courses the University collaborates with the Dutch Post-Academic Education Centre for Pharmaceutical Sciences.
With a course curriculum of over 200 meetings each year, this centre has a widespread experience in organizing courses for community pharmacists, hospital pharmacists, industrial pharmacists and physicians.
Regulatory and private partners support the consortium in the implementation, organisation and promotion of Eu2P trainings.
- They ensure that the academic content of the course meets the relevant professional needs
- They contribute to the transfer of knowledge and skills
- They offer complementary skilled courses
- They provide additional resources such as grants for future students
- They offer placement possibilities to perform a research project
- They are associated to the Eu2P joint diploma awards
Agence nationale de sécurité du médicament et des produits de santé
The Agence nationale de sécurité du médicament et des produits de santé (Ansm) is in charge of the evaluation, the control and the examination of health products in France. This agency is also responsible of the pharmacovigilance system in France.
Four main missions of the agency are defined:
1. The scientific and medical economic evaluation
2. The control in laboratory and the control of the advertising
3. The inspection on sites
4. The information of the professionals of health and the public
The Ansm brings its experience on Medicines risk communication.
European Medicines Agency
The European Medicines Agency (EMA) coordinates pharmacovigilance activities in Europe in collaboration with national authorities. The European Medicines Agency brings its expertise within the regulatory aspect of pharmacovigilance, risk management and pharmacoepidemiology.
F. Hoffmann-La Roche Ltd
Boehringer Ingelheim International GmbH
Eli Lilly and Company Limited
GlaxoSmithKline Research and Development Ltd
H. Lundbeck A/S
Janssen Pharmaceutica NV
Laboratorios Almirall SA
Novartis Pharma AG
Novo Nordisk A/S
Sanofi-aventis Recherche et Développement
UCB Pharma SA
The Karolinska Institutet is a World Health Organization collaborating centre in medicines utilization studies and clinical pharmacological services with expertise in aggregate and population-based data; it includes one of the regional pharmacovigilance centres in Sweden providing real-life skills in benefit-risk assessments with both a regulatory and public health focus applying medicines utilization data to adverse drug reporting.
The Karolinska Institutet provides the Master in public health sciences specialized in epidemiology and health economics.
STUDY WITH Eu2P
FEES & EXPENSES