EMEA RISK MANAGEMENT – PHARMACOVIGILENCE
October 1st, 2005
BY KEITH NUTHALLPHARMACEUTICAL manufacturers should hone their monitoring of the effects of a new medicine on patients by focusing on potential risks identified by sophisticated pre- and post-marketing approval analysis, says the European Medicines Agency (EMEA). It has issued a detailed guideline on conducting such risk assessments, saying: "Planning of pharmacovigilance might be improved if it were more closely based on product specific issues identified from...data and pharmacological principles". Such planning would guide the use of routinely collected health ...
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