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The Spanish Medicines Agency has developed new initiatives with the aim of complementing the spontaneous report classical approach. Among these initiatives, BIFAP, an integral primary care based database which includes demographics, prescriptions, diagnoses and lab and test results, has recently been developed together with the Spanish Centre for Pharmacoepidemiologic Research (CEIFE) and covers a population of about 2.2 million patients. AEMPS has experience in performing epidemiological studies both using healthcare databases or field studies. AEMPS is also the coordinating centre for the Spontaneous Reporting Scheme in Spain, and is the administrator of the database supporting this program (FEDRA), which includes more than 130,000 reports. B/R assessment is one of its main activities as a regulatory agency.
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Amgen discovers, develops, manufactures and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe and effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives.
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AstraZeneca is a major global pharmaceutical company with headquarters in London, UK, and major R&D sites in Sweden, UK and the US. In 2008 sales totalled $31.6 billion and R&D spend was >$5 billion. The AstraZeneca company has strong market and R&D presence in disease areas such as gastrointestinal, cardiovascular, oncology, neuroscience, infection, and respiratory and inflammation. The company has extensive experience on pharmacovigilance and B-R assessments.
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Bayer Pharma is one of the ten largest specialty pharmaceutical companies in the world, headquartered in Germany. Its research and business activities are focused on the following areas: Diagnostic Imaging, General Medicine, Specialty Medicine and Women's Healthcare. With innovative products, Bayer aims for leading positions in specialized markets worldwide. In 2009 Bayer Pharma generated sales of more than €10,4 billion in over 100 countries. Over 36000 people work for Bayer, more than 5900 in Research and Development alone. Using new ideas, Bayer aims to make a contribution to medical progress and strives to improve the quality of life.
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The European Medicines Agency (EMA) is the European Union (EU) regulatory body responsible for coordinating the EU Phamacovigilance System. As such, it coordinates the scientific resources of over 40 national competent authorities and a network of over 4,000 EU experts in 30 EU and EEA-EFTA countries. Its international activities include working with the WHO, ICH and many leading regulatory authorities worldwide (FDA, Japan, Health Canada, etc.) The EMA manages EudraVigilance, a pan-EU database and network for reporting and evaluating suspected adverse reactions throughout the entire lifecycle of medicines within the EEA, and has access to the data of EPIC/THIN (a medical research database of anonymised patient records). Through the establishment of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP), the EMA is ideally placed to ensure the effective and rapid dissemination of the scientific output of the PROTECT consortium to relevant stakeholders.
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Headquartered in Basel, Switzerland, Roche is one of the world’s leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As the world’s biggest biotech company and an innovator of products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people’s health and quality of life. Roche is the world leader in in-vitro diagnostics and drugs for cancer and transplantation, and is a market leader in virology. It is also active in other major therapeutic areas such as autoimmune diseases, inflammatory and metabolic disorders and diseases of the central nervous system.
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The Catalan Institute of Pharmacology is a non-profit institution associated with both the Clinical Pharmacology Service of Hospital Universitari Vall d'Hebron (Institut Català de la Salut), and the Department of Pharmacology and Therapeutics of the Autonomous University of Barcelona (UAB). Research activities mainly focus on pharmacoepidemiology. In addition to the voluntary reporting scheme (yellow card) and in-hospital pharmacovigilance, FICF designs, coordinates and participates in several multicentre studies, with different observational epidemiological methods on the relationship between specific diseases and the use of drugs.
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The Spanish Centre for Pharmacoepidemiologic Research is a non-profit research unit created in 1994. Its mission is to provide high quality research on drug safety and effectiveness, by means of epidemiologic studies utilizing computerised databases. Four main sources of information are used: GPRD and THIN in the UK, BIFAP Database in Spain, and the Saskatchewan Database in Canada. CEIFE collaborates with industry, regulatory authorities and other universities at national and international level.
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One of the world's leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Since 1981, the company has grown from a small start-up to a diversified enterprise with more than 12,000 employees in locations spanning the globe and 2008 revenues of $4.6 billion. With many established products and services helping patients in nearly 100 countries, Genzyme is a leader in the effort to develop and apply the most advanced technologies in the life sciences. The company's products and services are focused on rare inherited disorders, kidney disease, orthopaedics, cancer, transplant and immune disease, and diagnostic testing. Genzyme's commitment to innovation continues today with a substantial development program focused on these fields, as well as cardiovascular disease, neurodegenerative diseases, and other areas of unmet medical need.
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Headquartered in the UK and with operations based in the US, GSK is one of the industry leaders, with an estimated seven per cent of the world's pharmaceutical market. GSK is a research-based pharmaceutical company, committed to tackling the three "priority" diseases identified by the World Health Organization: HIV/AIDS, tuberculosis and malaria. Over 15,000 people work in our research teams to discover new medicines. GSK has extensive experience in the fields of pharmacovigilance and pharmacoepidemiology, has developed novel signal detection methodology and has expertise in signal management, benefit:risk methodologies and use of healthcare databases.
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GPRD is a dedicated multi-disciplinary team based at the Medicines & Healthcare products Regulatory Agency (MHRA - see below) in London who operate the GPRD, the gold standard of longitudinal anonymised patient databases from primary care. Currently data are being collected on over 3.6 million active patients (approx. 13 million total) from around 450 primary care practices throughout the UK. It is the largest and most comprehensive source of data of its kind and is used worldwide for research by the pharmaceutical industry, clinical research organisations, regulators, government departments and leading academic institutions. Through ExEtrac, a new exposure to medicine and event-tracking system, there is the potential to have access to data streams from the UK, a range of other European countries and the USA, covering in total a number of 40 million lives.
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Lundbeck is an international pharmaceutical company engaged in research and development, production, marketing and sale of of drugs for the treatment of psychiatric and neurological disorders. Lundbeck has extensive experience in the fields of pharmacovigilance and pharmacoepidemiology with use of healthcare databases.
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Imperial College London embodies and delivers world class scholarship, education and research in science, engineering and medicine, with particular regard to their application in industry, commerce and healthcare. The Department of Epidemiology and Public Health has a focus on aetiological research in chronic diseases epidemiology investigating both genetic and environmental causes of disease, and has internationally recognised expertise in Bayesian statistics. It has substantial funding from the UK Research Councils and governmental departments as well as funding from charities and the EU. Cutting edge computing equipment and support is available to handle the large databases and statistical computational demands of the work.
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The laboratory U 872 - Centre de Recherche des Cordeliers Inserm (CRC, team 20) is a research unit placed under the responsibility of “Institut national de la santé et de la recherche médicale” (Inserm) and the University Paris Descartes. The Inserm team performs research in knowledge engineering and develops knowledge based systems in medicine. Part of the team is also responsible for the electronic healthcare record of the Georges Pompidou Hospital in Paris. The team is a partner of the VigiTerms project funded by the French government that aims to build a knowledge management platform for documentation of case reports and signal detection in pharmacovigilance.
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The International Alliance of Patients’ Organizations is a patient led alliance of 200 member organisations representing patients regardless of disease area or nationality. Our full members are patients’ organisations representing an estimated total of 365 million patients worldwide. In addition IAPO links with over 1,300 patient and consumer groups globally of which over 800 are based in Europe.
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LA-SER is a Research and Development SME, based in Pepiniere Paris Sante Cochin, European headquarters in London. It was awarded the title of ‘Young Innovative Enterprise’ by the French Ministry of Research and Industry for its R&D activities in pharmacacoepidemiology, including PGRx. PGRx is a population-based, pharmacoepidemiologic system for the assessment of the risks and benefits of medicines, launched in France in 2007. It consists of the systematic collection of cases of adverse events and of a pool of potential referents to be matched to these cases for case-control analysis and surveillance. 270 drugs and all marketed vaccines are systematically documented, including drugs targeted in EMA Risk Management Plans.
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The Danish Medicines Agency, under the Ministry of Health and Prevention, is the regulatory agency for the authorisation of medicinal products in Denmark. The DKMA is experienced in the post-marketing surveillance of medicinal products and collects and handles reports of adverse reactions from different sources. Of note, the DKMA prepares statistics and analyses on the basis of the Register of Medicinal Product Statistics, which is a database that contains figures on the total sale of medicines in Denmark from 1994 until present time; figures on sale of prescription medicines cover the whole population. In the database it is possible to link sales of prescription medi¬cinal products with individuals. The information is collected from Danish community pharmacies, hospital pharmacies, the National Central Laboratory of the Danish Health System and the National Veterinary Institute, which registers every dispatch or delivery of medicinal products in Denmark.
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The Department for Medical Informatics, Biometry and Epidemiology is part of the Medical School of the Ludwig-Maximilians-University of Munich, Germany. The LMU ranks officially among the first-class universities in Germany. The Department’s main research areas are clinical trials, prognostic research, bioinformatics, and pharmacoepidemiology. In addition, the Department runs post-graduate Master training courses for public health (MPH), and Epidemiology (MSc Epi). In about 1994 it developed the concept of regional pharmacovigilance centers with a strong epidemiological backing by using drug consumption data for estimating incidences of ADRs. This Network of Regional Pharmacovigilance Centers is funded by the German Drug Authority (BfArM). Of note, the Department has access to the spontaneous reports database of the BfArM. In addition, collaborations exist with the Drug Commission of the German Medical Association, the Central Research Institute of Outpatient Health Care, and the Bavarian Association of Social Health Insurance accredited Physicians, which runs a population-based data base covering 10.5 millions people. Further relevant research topics are drug utilisation research with special emphasis on pregnancy, persistence and risk assessment.
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The Mario Negri Institute for Pharmacological Research is a 45-year old not-for-profit biomedical research organisation. The Institute’s main aim is to help defend human health and life. The Institute’s research programmes span from the molecular level to the whole human being and populations. The findings help develop new drugs, and render existing ones more effective and safer. The main research topics include cancer, nervous and mental illnesses, cardiovascular and kidney diseases, rare diseases, toxic effects of environmental contaminants, and mother and child’s health. The Institute is also involved in research on pain relief and drug addiction. The Institute employs around 900 people and has published more than 11,000 scientific papers in peer-reviewed international journals.
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The MHRA is the UK regulatory agency for medicines and medical devices, and is an executive agency of the Department of Health. The Agency has a well established scheme for reporting adverse drug reactions and collects and handles reports of adverse reactions from different sources including reports directly from patients. The MHRA has also played a leading role in the development and implementation of risk management plans and continues to input into the EU review of the importance of these plans. The General Practice Research Database (GPRD - see above) which is the world's largest computerised database of anonymised longitudinal medical records from primary care, that is linked with other healthcare data, is also maintained by MHRA.
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Merck Serono is the division for innovative prescription pharmaceuticals of Merck, a global pharmaceutical and chemical group. Headquartered in Geneva, Switzerland, Merck Serono discovers, develops, manufactures and markets innovative small molecules and biopharmaceuticals to help patients with unmet medical needs. Its North American business operates in the United States and Canada as EMD Serono.
With an annual R&D expenditure of around € 1bn, Merck Serono is committed to growing its business in specialist-focused therapeutic areas including neurodegenerative diseases, oncology, fertility and endocrinology, as well as new areas potentially arising out of research and development in autoimmune and inflammatory diseases.
The Merck Serono contribution to PROTECT originates from its Global Drug Safety department, a multidisciplinary team or physicians, scientists, compliance officers and IT support, responsible for the maintenance of the Global Safety system of the Company, and of the Safety Risk Management of its Development and Marketed portfolio (over 600 drugs).
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Novartis Pharma AG is a multinational pharmaceutical company based in Basel, Switzerland with approximately 100 000 associates in 140 countries worldwide. Novartis focuses on discovering and developing innovative products, is committed to innovative research and participates in collaborative research projects with other industry and academic partners. Novartis has extensive experience in pharmacoepidemiology, pharmacovigilance, signal detection and benefit risk methods within the framework of integrated safety in development.
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Novo Nordisk is a healthcare company and a world leader in diabetes care. In addition, Novo Nordisk has a leading position within areas such as haemostasis management, growth hormone therapy and hormone replacement therapy.
Novo Nordisk manufactures and markets pharmaceutical products and services that make a significant difference to patients, the medical profession and society. Headquartered in Denmark, Novo Nordisk employs more than 29,300 employees in 76 countries, and markets its products in 179 countries.
Novo Nordisk is a member of EFPIA and the Novo Nordisk contribution to PROTECT originates from Research and Development Management.
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Outcome Europe Sarl is a research and technology SME with headquarters in Switzerland that provides studies, registries and technologies for evaluating real-world outcomes (safety, effectiveness, quality). Outcome’s programmes (registries, cohort studies, late phase studies, performance linked access systems, quality initiatives) have collected data on more than 9 million patients from more than 2000 organisations, thousands of physicians and from patients directly. Scientifically, Outcome is active in methods and best practices related to observational research. Technologically, Outcome provides advanced data collection and processing systems (web, voice, other) and real-time analytics and reporting. Outcome is a leader in developing interoperability standards and methods and works extensively with electronic health record systems.
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Pfizer is the world's largest research-based biomedical and pharmaceutical company. Pfizer has substantial experience in risk management, pharmacoepidemiology, pharmacovigilance, and signal detection methods within its integrated safety division. The safety epidemiology group at Pfizer partners with development teams to bring new medicines to patients by providing epidemiologic research strategies throughout the development continuum. Pfizer and the epidemiology group are committed to the conduct of research meeting the highest scientific and ethical standards to assess the benefits and risks of our medicines.
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The Poznan University of Medical Sciences (PUMS) is a leading Polish medical centre with over 80 years of academic experience, well equipped for research in basic medical sciences, clinical investigations, diagnostics and treatment. Teaching and research are mainly based on the co-operation with five Clinical Hospitals as well as with other city hospitals, while advanced research at the University is carried out in virtually every field of modern medicine. The Department of Medical Genetics is involved in scientific projects concerning congenital malformations and mental retardation. Organizer and seat of the Polish Registry of Congenital Malformation (since 1997). The PRCM currently covers the whole Poland (over 400,000 births/year), collaborating with 1,800 medical care units in Poland, and is an associate member of the EUROCAT, while Wielkopolska Registry, a part of the PRCM, is a full member of the EUROCAT.
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The Unit of Pharmacoepidemiology & Pharmacoeconomics (PE2) is part of the Department of Pharmacy at the University of Groningen (RUG). The Department of Pharmacy belongs to the Faculty of Mathematics and Natural Sciences (FMNS) of the University of Groningen (RUG). The Unit of PE2 participates in the Graduate School for Health Services Research SHARE. Within SHARE, the Unit of PE2 constitutes the section of ”Evidence-based Medicine”, together with the 3 groups from the University Medical Centre Groningen (UMCG), i.e. Epidemiology, Clinical Pharmacology and GP Medicine.
The Unit of PE2 conducts original research to (i) assess benefit-risk profiles of drugs (ii) identify and analyse gaps between scientific knowledge/evidence-based guidelines and actual drug prescribing and use, (iii) develop, test and analyse (including cost-effectiveness) strategies to implement evidence-based interventions in every day practice. The research focuses on topics related to specific potentially high-risk groups, such as pregnant women, infants, children and chronically-ill persons (kidney and cardiovascular diseases). The research in reproductive pharmacovigilance aims to collect information on risks and benefits of drugs used during pregnancy. The Unit of PE2 closely collaborates with the EUROCAT-network of registries of birth defects on the development and optimisation of a birth defect case-control monitoring system in Europe (EUROmediCAT).
EUROCAT is the European network of population-based congenital anomaly registers for the epidemiologic surveillance of congenital anomalies started in 1979. The network is multinational (20 countries), and multidisciplinary (clinicians – paediatricians, obstetricians, medical geneticists, epidemiologists, statisticians, pharmacists etc). The EUROCAT database contains individual records of livebirths, stillbirths and terminations of pregnancy with congenital anomaly from 40 registries in 20 countries. In total, there are more than 375,000 cases recorded 1980 - 2004 in the database, along with information about the number of births in the population.
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Sanofi-Aventis is among the worldwide top three major pharmaceutical companies, EFPIA member, and headquartered in Europe. Sanofi-Aventis is a research-based company developing innovative medicines in several medical domains such as Metabolism, Cardiovascular, Oncology, Diabetes, and Neurology etc.
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Takeda is a research-based global company with its main focus on pharmaceuticals. It is the oldest and largest pharmaceutical company in Japan, and among the leaders in the world with subsidiaries in the US, EU and Asia. Takeda discovers, develops, manufactures and markets a broad range of pharmaceutical products to strive toward better health for individuals and progress in medicine. Takeda R&D concentrates on the four core therapeutic areas: lifestyle-related diseases, oncology and urological diseases, central nervous system disease and gastroenterological diseases in order to provide new drugs to the patients who need them at the earliest possible date. The Takeda Global Research and Development Centre (Europe) was initially based in Frankfurt, and was established in the UK in 1998.
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Link to website: www.takeda.com |
The Uppsala Monitoring Centre (UMC) is the field-name of the WHO Collaborating Centre for International Drug Monitoring in Uppsala, Sweden. The UMC is an independent centre of scientific excellence responsible for the worldwide collection of reports on suspected adverse drug reactions and the management of the WHO Programme for International Drug Monitoring. Through a range of products and services, based on the WHO Global individual case safety reports database, VigiBase, the UMC provides essential resources for regulatory agencies, health professionals, researchers, and the pharmaceutical industry. Its research focus includes the development and application of data mining methods within healthcare data; particularly electronic patient records and spontaneous reports.
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As one of the UK's leading universities, Newcastle University comprises more than 18,000 students and 4,500 staff. The Wolfson Unit of Clinical Pharmacology, part of the Institute of Cellular Medicine in the Faculty of Medicine, will represent the Newcastle University in the Consortium. This hosts the UK National Teratology Information Service, which is part of the European Network of Teratology Information Services (ENTIS). This network collects and evaluates data for the primary prevention of birth defects and developmental disorders.
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The Utrecht Pharmacoepidemiology Group is part of the Utrecht Institute for Pharmaceutical Sciences of the Utrecht University and is one of the leading academic groups in the world in the interface between pharmaco¬epide¬mio¬logy, pharmacovigilance and drug innovation. The group has an extensive research record on new methods of data collection, study design and data analysis delivering >50 papers per year. Key features in the profile of the group over the years have been new methods on drug channelling, exposure ascertain¬ment, rare events, signal detection and evaluation, adjustment for confounding, record linkage, pharmaco¬genetics and implications for public health and weighing of B/R.
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