#ICYMI 2 – In Case You Missed It – Featured Articles from the Archives
Our expert team has written over 300 insightful articles on all aspects of regulatory affairs. Here, we are highlighting some of the best writing from our recent archive in #ICYMI. In this second edition of #ICYMI (In Case You Missed It) we are featuring articles on issues as diverse as PV inspections, Eudravigilance, how social media has an impact on GVP and the responsibilities of an EU Authorised Representative for medical devices.
The new Eudravigilance system, aimed at improving adverse event reporting and safety monitoring, was launched today (November 22nd 2017).
The new system will allow for better collaboration with the World Health Organisation (WHO) by providing access to the WHO’s Uppsala Monitoring Centre (WHO-UMC).
The responsibilities and role of the EU Authorised Representative (or EC Rep) is now in the spotlight as a result of the UK’s decision to leave the EU. Many companies have previously chosen EU Authorised Representatives from the UK and, as a result of the referendum, will now need to choose a new representative within the EU. In this blog post we will look at the 10 of the main responsibilities of an EU Authorised Representative. 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. Pharmacovigilance professionals are aware that adverse reactions can be reported from a variety of sources – patients, healthcare professionals, competent authorities or marketing authorisation holders. Robust Pharmacovigilance however depends greatly on complete and timely reporting of adverse reactions. And herein lies the problem – it is estimated that over 90% of adverse drug reactions are under-reported. Read more here.
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.
We will feature many more articles from our archive as the #ICYMI In Case You Missed It series progresses. Feel free to share any articles of interest by using any of the links below.