A risk-based audit should cover governance, risk management and internal controls of all parts of the pharmacovigilance system, as well as pharmacovigilance activities delegated to another organisation such as PharmAdvice, and you should assess risks at both the strategic, the tactical and the operational level.

In this article, you will find a list of the most common ongoing and annual pharmacovigilance activities and the documentation you are required to provide for each activity.

I am happy to announce that Christina Guiton has joined the PharmAdvice pharmacovigilance team as QPPV and pharmacovigilance manager.

Christina Guiton is a medical doctor with more than 20 years of experience within the pharma industry.

On 22 November 2017, EMA launched the new EudraVigilance system. All marketing authorisation holders (MAHs) were required to monitor EudraVigilance data with a start date of 22 February 2018.
In August 2022 EMA and the European Commission agreed to further extend the pilot until the end of 2023.