All January 2022 articles
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Journal10 years of pharmacovigilance legislation: the perspective of a national agency
In 2012, the new pharmacovigilance legislation came into force, which established a uniform standard for the safety monitoring of medicines in Europe. These new legal requirements resulted in impactful changes, including the creation of a further scientific committee at the European Medicines Agency’s (EMA), the Pharmacovigilance Risk Assessment Committee (PRAC). It also resulted in a new framework for signal management, the establishment of a periodic safety update report (PSUR) single assessment and additional requirements for risk management plans (RMPs). This article reflects upon the past 10 years’ experience, including the recent pandemic. Suggestions are made on areas where the legal framework may need to be further adapted to a changing regulatory environment.
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Meeting ReportThe EMA’s Veterinary Big Data Stakeholder Forum (Part 1)
The Veterinary Big Data Stakeholder Forum, the first event of its kind and jointly organised by the European Medicines Agency and Heads of Medicines Agencies, took place on 1 and 2 June 2021 as a virtual event with over 500 participants globally connected.
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FocusClinical Trial Information System: overview, opportunities and challenges
The implementation of the Clinical Trial Information System (CTIS), from 31 January 2022, will facilitate the day-to-day business of sponsors of clinical trials by harmonising submission and maintenance of trial applications, assessment and supervision of trials, while promoting patient safety and transparency…