From June 30, 2022, EudraVigilance users will need to report individual cases of suspected side effects using the ISO ICSR / ICH E2B R3 format and related ISO standard terminology for pharmaceutical form and route of administration. The new XCOMP system no longer...

Internet Explorer is coming to end of its lifetime on 15th of June 2022 and EMA has given us almost no instructions how to proceed with usage of XEVMPD. Not to worry, read below to see what you should do if you face problems in June. Following up to our blog post...

By Martti Ahtola & Dominik Hodbod   We previously wrote about the background and current situation of the EMA’s signal detection pilot program that was extended from 2018 until the end of 2022. During our research into the topic, we requested the European...

Brexit is a thing of the past. Without going into too much detail, let’s say that in the context of regulatory activities for medicinal products and devices some of the related updates and transition were completed by the end of 2020 and last parts (like the...

We recently wrote a blog about the statistics on number of deaths in the EU and the efficacy of pharmacovigilance activities. We contacted Eurostat for additional information for the statistics and received a file with detailed information about reported deaths per...

What is the Digital Application Dataset Integration Project? Martti Ahtola and Sabiha Rahman Mim   Digital Application Dataset Integration (DADI) project was initially announced in March 2021 and since then, there have been couple of updates from the project...

In 2018, European Medicines Agency (EMA) started a pilot program for signal management during which the marketing authorization holders (MAHs) in EU are required to continuously monitor EudraVigilance (EV) data if their product contains an active pharmaceutical...

By Martti Ahtola and Sabiha Rahman Mim   EUDAMED is a new European system for medical devices that aims to put all aspects of registering, monitoring, and managing information about products among different industry actors. This blog explains what the background...

Martti’s ramblings about the WHO and number of deaths caused by ADRs   Information published and communicated by the World Health Organization (WHO) is trusted by nations, the authorities, and by the people. In the past two years we have relied on the WHO for...