It has been a very busy year for the Acorn Regulatory pharmacovigilance team. Over the course of the year we have worked with a large number of companies around the world. Our team has also produced a large number of well received articles about a range of pharmacovigilance issues. Here are the 5 most read pharmacovigilance articles on AcornRegulatory.com in the past 12 months.
A pharmacovigilance inspection can be a daunting prospect for many companies. Since 2002 we have worked with countless companies to guide them through their inspections. In this article, we look at the measures that your company can take to be prepared. Read more here.
Good Pharmacovigilance Practice (GVP) at its core aims to prevent harm from adverse reactions in humans from medicines and to promote the safe and effective use of medicinal products. Read more here.
In our second piece in a series about package leaflets, we look at consultations with target patient groups and, in particular, bridging reports.In a previous article we presented one option to meet this requirement which was the submission of a User Test Outcome Report. However, not every package leaflet needs to be subjected to a separate test and alternative evidence may take the format of a Bridging Report.Read more here.
In this blog we look at the Periodic Safety Update Single Assessment or PSUSA. Periodic safety update reports (PSURs) are pharmacovigilance documents submitted by marketing authorisation holders (MAHs) at defined time points during the post-authorization phase of their medicinal products. PSURs provide a comprehensive and critical analysis of the risk-benefit balance of a medicinal product taking into account new or emerging safety information. Read more here.
Since the introduction of the pharmacovigilance legislation in 2010, a commitment to a simplified approach to adverse event reporting was introduced by the EMA (Articles 107(3) and 107a(4) of Directive 2001/83/EC). This approach would only apply however following an independent audit of the EudraVigilance database.Ad interim, the adverse reaction reporting is based on the provisions set out in Article 2(4), Article 2(5) and Article 2(6) of Directive 2010/84/EU and in line with national legislation and guidance where applicable. This is referred to as the so-called ‘Interim period’ which continues to be in place. Read more here.
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