Acorn Regulatory’s Essential Guide to Pharmacovigilance
The Acorn Regulatory PV team works with a range of clients around the world. Our essential guide looks at the most read and downloaded articles that were written by the team in the past 24 months.
Post authorisation safety studies (PASS) are defined in Article 1(15) of Directive 2001/83/EC as studies carried out after a medicine has been authorised to obtain further information on a medicine’s safety or to measure the effectiveness of risk-management measures. In this article, our Medical Manager, Dr. Danica Cvetkovic, looks at the PASS and the link with Risk Minimisation Plans (RMP’s).
Brexit will impact on many aspects of the life sciences sector. One of the areas that will be most impacted will be the role of the Qualified Person for Pharmacovigilance (the QPPV). In this article, we consider the impact that the UK’s exit from the EU will have on the role and the measures that companies will need to take once Brexit happens.
Scientific literature is a significant source of information for the monitoring of the safety profile of medicinal products, particularly in relation to the detection of new safety signals or emerging safety issues.
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. We look at the measures that your company can take to be prepared.
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