December 18, 2015

EMA Meeting – Clinical Trials Portal and Union database stakeholders meeting

8th December 2015 – Canary Wharf.

This EMA (European Medicines Agency) meeting was attended mostly by pharmaceutical companies, clinical research organisations, representatives from the ethics committees from the Member States and 5 patient representatives.

There was a lot of discussion about time lines regarding user testing and the launch of version 1 of the Clinical Trials Portal. A requirement of 15 groups reporting on their experience as user testers will take place from 11-16th March 2016. The testing will be about the use of the website and not necessarily about the technical side of the website. A webinar will be held in February for those participants in order to provide instructions on accessibility.

Medical Product Dictionary, Auxiliary Medical Products and Associated Medical Products need to be harmonised so that entry of Clinical Trial Data into the new EU Clinical Trials register will rely on the same information. Under the new rules only one substantial modification is permitted.  A Q&A page is currently being developed for guidance.

There will be a transition period of one year for the pharmaceutical companies, clinical research organisations and academic institutions and after 3 years all Clinical Trials are governed by new legislation. Member Sates have to start working with the new directive. A lot of guidance will be needed by the companies, such as site inspections inside the EU as well as outside. At the moment there is no consistency in requirements by the Member States, this will need to be harmonised too. A discussion followed about reporting SUSAR (suspected unexpected serious adverse reactions) and ADR (adverse drug reaction) and corrective measurement taken by the Member States and the sponsors.
The next meeting will take place in February 2016.

Jose Drabwell, IPOPI President