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The ENCePP Steering Group was established in 2010 to oversee the mid to long-term implementation of the ENCePP project. The Steering Group consists of 17 members and provides a good balance of expertise (regulatory, conduct of pharmacoepidemiological studies, patients, healthcare professionals, ethical issues). Six members of the Steering Group are elected representatives from the ENCePP Plenary. From 2014 onwards the term of service of the Steering Group is three years.
The ENCePP Steering Group defines and safeguards the objectives and principles of ENCePP and decides on operational tasks of the network. The Steering Group is the highest authority of ENCePP and thus is its final decision making body. It acts as adjudicator in case of discrepancies or complaints in the context of the ENCePP network.
Related information:
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Mandate of the ENCePP Steering Group
» Steering Group meeting reports
| No. | Representing | Name | Affiliation |
|---|---|---|---|
1 |
ENCePP | Cécile Droz-Perroteau | Pharmacoepidemiologist, Director of Bordeaux PharmacoEpi reasearch platform, France |
2 |
ENCePP | Daniel Prieto-Alhambra | Research Co-ordinator for the IMI2 European Health Data and Evidence Network (EHDEN); Erasmus University Medical Center, the Netherlands; Oxford University, UK |
3 |
ENCePP | Francesco Salvo | Associate Professor, Hospital Practitioner, Bordeaux University Hospital, Bordeaux Pharmacovigilance Centre, INSERM Research Centre, France |
4 |
ENCePP | Helga Gardarsdottir | Associate Professor at the Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht University, the Netherlands |
5 |
ENCePP | Rosa Gini | Head of the Medical Informatics and Pharmacoepidemiology Unit, ARS Toscana, Regional Agency of Health – Agenzia Regionale di Sanità (ARS), Florence, Italy |
6 |
ENCePP | Susana Perez-Gutthann | Vice President, Global Head Epidemiology, RTI Health Solutions, Barcelona, Spain |
7 |
EMA | Ana Hidalgo-Simon | Head of Advanced Therapies, Human Division, European Medicines Agency, Amsterdam, the Netherlands |
8 |
EMA | Gianmario Candore | Statistician, Data Analytics and Methods Task Force, European Medicines Agency, Amsterdam, the Netherlands |
9 |
EMA | Andreas Kouroumalis | Scientific Officer, Oncology and Haematology Office, Human Division, European Medicines Agency, Amsterdam, the Netherlands |
10 |
HMA | Kåre Kemp | Head of EU Pharmacovigilance Section, Danish Medicines Agency, Copenhagen, Denmark |
11 |
CHMP | Johann Lodewijk Hillege | Medicines Evaluation Board, Utrecht, The Netherlands |
12 |
COMP | Frauke Naumann-Winter | Federal Institute for Drugs and Medical Devices, Bonn, Germany |
13 |
PRAC | Daniel Morales | GP & Epidemiologist, University of Dundee, United Kingdom; University of Southern Denmark, Denmark |
14 |
PCWP | Iryna Vlasenko | European Chapter of the International Diabetes Federation, Brussels, Belgium |
15 |
ISPE | Arnold K. Chan | Director of the Health Data Research Centre, National Taiwan University, Taiwan |
16 |
ISoP | Gianluca Trifirò | Professor of Pharmacology, Department of Diagnostics and Public Health, University of Verona, Italy |
17 |
ISPOR | Lucinda S. Orsini | Associate Chief Science Officer, International Society for Pharmacoeconomics and Outcomes Research, USA |
| Observer | EFPIA | Patrice Verpillat | Global Epidemiology, Merck Group, Germany |
| Observer | FDA | Wei Hua | Associate Director, Center for Drug Evaluation and Research, Office of Surveillance and Epidemiology, Office of Pharmacovigilance and Epidemiology, Division of Epidemiology, U.S. Food and Drug Administration, USA |
| Observer | FDA | Narayan Nair | Division Director, Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, USA |
| Observer | Health Canada | Craig Simon | Acting Director, Health Products Surveillance and Epidemiology Bureau, Marketed Health Products Directorate, Health Products and Food Branch, Health Canada, Canada |
| EMA | European Medicines Agency |
| HMA | Heads of Medicines Agencies |
| CHMP | Committee for Medicinal Products for Human Use |
| COMP | Committee for Orphan Medicinal Products |
| PRAC | Pharmacovigilance Risk Assessment Committee |
| PCWP | Patients' and Consumers' Working Party |
| ISPE | International Society for Pharmacoepidemiology |
| ISoP | International Society of Pharmacovigilance |
| ISPOR | International Society for Pharmacoeconomics and Outcomes Research (The professional society for health economics and outcomes research) |
| EFPIA | European Federation of Pharmaceutical Industries and Associations |
| FDA | Food and Drug Administration |