How to Become EU QPPV?

<p><strong>The Qualified Person for Pharmacovigilance (QPPV) is the primary contact point for pharmacovigilance (PV) in a country or region (EU) on behalf of a pharmaceutical company. All pharmaceutical companies in the EU and in some other countries are legally required to have at least one QPPV. In this short article, we are focusing on the EU because this is the region where QPPV will have the most important role.</strong></p> <p>According to the&nbsp;<a href="https://www.ema.europa.eu/en/about-us/what-we-do/legal-framework" rel="noopener ugc nofollow" target="_blank">legislation</a>, the EU QPPV needs to have a thorough understanding of all EU pharmacovigilance regulations and&nbsp;<a href="https://www.ema.europa.eu/en/human-regulatory/post-authorisation/pharmacovigilance/good-pharmacovigilance-practices" rel="noopener ugc nofollow" target="_blank">Good Pharmacovigilance Practices</a>&nbsp;(GVP). The EU QPPV is responsible for the establishment and oversight of the pharmaceutical company&rsquo;s PV system. PV system is a collection of processes that ensure the continuous monitoring of the benefit-risk profile of the medicine. Basically, the pharmacovigilance activities ensure that the drug is safe in real life, not just in controlled clinical trials.</p> <p><a href="https://medium.com/@tepsivo/how-to-become-eu-qppv-19b6bcb35357"><strong>Read More</strong></a></p>
Tags: EU QPPV