Читать книгу Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition) - William Gregory - Страница 106

The EU has developed a comprehensive risk management strategy for all products in the EEA. This is a strategy that covers the entire life cycle of a product, and a risk analysis is required for every product upon approval (or during its marketing). A specific committee (PRAC), replacing the former PV Working Party, was set up in 2012 (see below). The goal is to have a set of pharmacovigilance activities and potential non-routine interventions designed to identify, characterize, prevent, and minimize risks relating to medicinal products, including the assessment of the effectiveness of these interventions.