Pharmacovigilance: an EU wide network experience
by Albert van der Zeijden, patient representative at the Pharmacovigilance Risk Assessment Committee and the Scientific Committee’s Patients’ and Consumers’ Working Party of the European Medicines Agency
It is the role of the Pharmacovigilance Risk Assessment Committee (PRAC) to avoid unnecessary harm by the use of medicines. As Directive 2010/84/EU states, “Pharmacovigilance rules are necessary for the protection of public health in order to prevent, detect and assess adverse reactions to medicinal products placed on the Union market, as the full safety profile of medicinal products can only be known after they have been placed on the market”. Safety is a relative concept and in the case of medicines always the outcome of the weighing of the benefits and risks of the medicine. This is the case on the regulatory
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