Pharmacovigilance in the European Union

Abstract

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Postmarket Safety Communication for Protection of Public Health: A Comparison of Regulatory Policy in Australia, Canada, the European Union, and the United States

“…45 Before the 2012 legislation, final decision making for pharmacovigilance was largely managed by EU countries' national regulatory agencies, with less consistency between countries. 46 The PRAC comprises representatives of EU regulatory agencies, individual scientific experts, and consumer and healthcare professional representatives. PRAC members take "rapporteur" roles for specific products, supported by their respective national regulatory agency and EMA staff.…”

Is Medical Schools, Curricula Content of Pharmacovigilance and Rational Pharmacotherapy- Related Subjects Sufficient for Future Physicians?

“…In theory, it is the goal of medical education to equip healthcare professionals with sufficient knowledge and skills that will enable them to initiate and follow safe and effective pharmacotherapy. 7 ADRs, account for approximately 5% of all acute hospitalizations, half of which are preventable, making them a global healthcare problem. [8][9][10] Many regulatory authorities are taking initiatives to decrease the detrimental effects of ADR underreporting, one of which is the inclusion of pharmacovigilance and ADR reporting as courses in medical and healthcare professionals' undergraduate level education.…”

“…[17][18][19][20][21][22]25,[30][31][32][33][34][35][36][37] However, as these interventions are costly or fail to produce clinically relevant and long-term effects, it is essential to provide pharmacovigilance education to healthcare students at the university level, which will be more effective in improving their knowledge and skills for a safer pharmacotherapy and future use of these skills in their career. 7,15,25 In 2016, a meeting organized by the Netherlands Pharmacovigilance Centre on behalf of the WHO stakeholders addressed and agreed on the pharmacovigilance competencies medical students need to have and the essential aspects of the subject that should be taught. 38 The five key aspects were understanding the importance of pharmacovigilance in the context of pharmacotherapy, and preventing, recognizing, managing, and reporting ADRs.…”