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Pharmacovigilance
Since the teratogenic effects of thalidomide appeared in 1961, focus on the risk of side effects has grown over the years. Structured information on side effects of drugs have been collected and tools have been developed in order to protect public health. Marketing Authorisation Holders (MAH) of one or more medicinal products within the EU are now obligated by EU legislation to collect, collate, evaluate and exchange information about adverse drug reactions. This is in order to ensure that rapid and appropriate responses, are made to potential safety issues related to medicinal products. From 20 November 2005 all MAH are obligated to send and receive Individual Case Safety Reports (ICSRs) electronically on their medicinal products. A-consult has a trained pharmacovigilance group to handle the specific tasks. Our pharmacovigilance group participates in educational groups, pharmacovigilance training courses, MedDRA courses. Staff from this group also submits comments to new directives and documents during hearings.. A-consult offers, as a third party provider, complete or tailored pharmacovigilance solutions to the pharmaceutical industry. |
A-consult a/s Gladsaxevej 3821 DK-2860 Søborg Denmark Tel: +45 38330080 Fax: +45 38330280 a-consult  a-consult.dkBusiness units: Site map |
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