Most Read Pharmacovigilance & Medical Articles of 2019
Our pharmacovigilance and medical teams have had a busy 2019. During the course of the year they have taken the time to write some very well received articles about PV, medical and clinical issues. Here, we have compiled 4 of the most read pieces from both teams in the past 12 months.
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Post Authorization Safety Studies – An Important Tool in PV
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). Read more here.
The UK PSMF – What Will It Look Like?
How will the Pharmacovigilance System Master File (PSMF) be impacted by the UK’s departure from the EU? What actions will companies with a UK Marketing Authorisation Holder (MAH) need to take in the event of a no-deal Brexit? In this short article, we consider the questions and give advice on what you need to consider and what you need to do, if you are impacted. Read more here.
What Will Happen To The QPPV Post Brexit?
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. Read more here.
The Increasing PV Obligations of Scientific Literature
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. However, the monitoring of literature with respect to pharmacovigilance is a huge undertaking, involving investment of excessive time, effort and cost for sifting through high volumes of multi-disciplinary journals. Read more here.
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