The general objective of WP7 is to identify training opportunities and support training programmes in the field addressed by PROTECT.
Specific objectives are to:
Identify training programme deliverables from this research project that would lend themselves to undergraduate and continuous education, and liaise with the IMI pharmacovigilance Training Consortium;
Identify best tools for disseminating project results and increasing expertise outside the consortium within PROTECT, pharmaceutical companies and other interested stakeholders;
Promote uptake of methodologies by interested stakeholders;
Identify training opportunities from within the consortium that may be offered to consortium partners (e.g. by exchange of expertise) and to students involved in the PhD programme on benefit-risk communication organised by the IMI pharmacovigilance Training Consortium.
The European Medicines Agency (EMA) is the EU regulatory body responsible for coordinating the EU Phamacovigilance System. As such, it co-ordinates 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.
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.
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.
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.
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.
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.