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Keeping Watch

Pharmacovigilance (PV) is the science related to the detection, assessment, understanding and prevention of adverse effects of medicines. The EU has a long tradition in PV. A clinic in Hamburg uncovered the development of phocomelia in newborns whose mothers had used thalidomide and in 1960, the EU first developed legislation on the matter. In 1995, the European Medicines Agency (EMEA) was created, and the EU PV legislation was revised in 2004, introducing the compulsory use of a Risk Management Plan in all new drug applications. Last year in 2008 there were EC proposals for new PV legislation.

From a regulatory point of view, the EMEA coordinates PV in Europe and national competent authorities (NCAs) have operational responsibilities over PV activities. One of the main responsibilities of the EMEA is to maintain and develop the PV database, which includes all suspected serious adverse reactions to medicines observed in the EU. The system is called EudraVigilance, and contains separate but similar databases of human and veterinary reactions. Europe requires drug companies to submit all received adverse reactions electronically, except under exceptional circumstances. The investment that the EMEA has made in order to facilitate the implementation of electronic submissions has been substantial: examples of this include an excellent help desk service, or allowing the submission of adverse drug event (ADE) information from small companies at no additional cost. Reporting can be done either using commercial software developed for this purpose or with a web tool called EVWEB, which can be accessed through the EudraVigilance homepage. However, not all the actors are on scene, as there are important agencies that do not participate, such as France. On the other hand, the individual NCAs have different requirements for electronic reporting. There are differences in the criteria used for ADE notification and even the language to be used, which makes life difficult for companies’ PV departments.


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Alejandro Arana is a Partner at Risk MR Pharmacovigilance Services. He studied medicine at the University of Zaragoza and specialised in Preventive Medicine, with a Masters in Public Health from Valencia University, and a Master of Science in Epidemiology from Erasmus University Medical School in Rotterdam. He has collaborated in several international projects on the epidemiology of ageing and dementia, and worked as an advisor for the Pan American Health Organization AIDS project in El Salvador. He is a Fellow, a member of the Board of Directors and co-chair of the Industry Council of the International Society of Pharmacoepidemiology (ISPE), and a member of the working group of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP).

Félix M Arellano is a Partner at Risk Management Resources. He is a physician specialising in clinical pharmacology and cofounder of Risk Management Resources. He was trained in pharmacoepidemiology at McGill University, Montreal, and is a Fellow of the International Society for Pharmacoepidemiology. Félix has held several positions in the areas of pharmacovigilance and pharmacoepidemiology in pharmaceutical companies in Europe and the US. He is currently serving his second elected term as a member of the Board of Directors of the International Society for Pharmacoepidemiology. Before founding RMR, he was the Chief Safety Officer at Pharmacia Corporation.

Teresa Cuchí is the founder and Managing Director of Actiomed, an independent contract safety surveillance organisation (CSO). Teresa is a physician with more than ten years of clinical experience in internal medicine, as well as epidemiological research focused on cancer, pharmacoepidemiology and drug safety. She holds a Masters Degree in Public Health and Clinical Epidemiology from Johns Hopkins University, Baltimore. She has held several positions in the area of pharmacovigilance in pharmaceutical companies in Spain and been the European Qualified Person for Pharmacovigilance for several companies at national and international level.

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Alejandro Arana
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Félix M Arellano
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Teresa Cuchí
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