cover image: Research networks involved in post-market pharmacosurveillance in the United States, United Kingdom, France, New Zealand, Australia, Norway and European Union : Réseaux de recherche engagés dans la pharmacovigilance après la commercialisation aux États-Unis, au Royaume-Uni, en France, en Nouvelle-Zélande, en Australie, en Norvège et dans l'Union européenne : leçons pour le Canada

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Research networks involved in post-market pharmacosurveillance in the United States, United Kingdom, France, New Zealand, Australia, Norway and European Union : Réseaux de recherche engagés dans la pharmacovigilance après la commercialisation aux États-Unis, au Royaume-Uni, en France, en Nouvelle-Zélande, en Australie, en Norvège et dans l'Union européenne : leçons pour le Canada

29 Apr 2008

In France for example, spontaneous case reports were the sole evidence supporting the removal of more than half (12 of the 21) of the drugs withdrawn from the market between 1998 and 2004,. [...] EMEA is working with the European Commission’s Directorate General for Research to establish a network of researchers and research centers to conduct commissioned studies referred to as the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCEPP), a network of pharmacoepidemiology centres, medical care centres, Automated Healthcare Databases and electronic Registries to [...] The main purpose of the DEcIDE network is to expeditiously develop valid scientific evidence about the comparative clinical effectiveness, safety, and appropriateness of health care items and services (Figure 5).53 FDA has also established a Memorandum of Understanding (MOU) with the Veteran’s Affairs to promote better data sharing between the FDA and the VA. [...] Lessons for Canada The MHRA also formed a series of independent advisory bodies made up of professionals, lay and patient representatives to provide advice to the Minister on issues related to the regulation of medicines; these bodies include the Commission on Human Medicines5 and the Independent Scientific Advisory Committee6. [...] The CHM's responsibilities include advising the UK government ministers on matters relating to human medicinal products, giving advice in relation to the safety, quality and efficacy of human medicinal products, and promoting the collection and investigation of information relating to adverse reactions for human medicines.
health government education compliance fda science and technology public health surveillance research drugs cancer medicine health care european medicines agency pharmaceutical preparations therapy pharmacovigilance product surveillance, postmarketing clinical trial adverse drug reaction reporting systems adverse reactions va health treatment health sciences medical drugs drug safety emea food and drug administration adverse effect santé publique nice cohort study médicaments adverse drug reaction bevacizumab us fda
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59
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Canada

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