On 15 October we had an interesting discussion on Observational Studies on Medications and patient support programmes in the new regulations that aroused a lot of interest. More than 90 people participated in the session with strong participation in questions and comments. 

With his extensive knowledge of the subject, Lluis Alcover informed us of the main legal issues raised by the new observational studies on medications and patient support programmes. We also learned the aspects that must be taken into account when conducting an observational study on medications with a very practical guide that María Gómez shared.

We analysed the patients’ point of view of patient support programmes, and Roberto Saldaña and Manuel Arellano told us how useful they are and some aspects for improvement.

And we ended the session with a reflection on the role of the Medication Research Ethics Committees (CEIMs) and the Autonomous Regions in the new regulations on observational studies on medications. Miguel Ángel Maciá and Manel Rabanal presented their points of view, discussing how this will be developed by the Catalonian Regional Government, and there was an open dialogue on collaboration between administrations to facilitate uniformity application of the Royal Decree, avoiding one of the risks that were pointed out: that there are different models that vary widely depending on the Autonomous Region.

You can download and view the video and the presentations using your access codes at for one month from today.

CEFI will be following up on this topic. Thank you for your interest in our training activities!

This post is also available in: Spanish

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