La version 2020 du guide méthodologique sur l’évaluation économique à la HAS appelle à une réflexion plus étayée sur les objectifs de l’évaluation au moment de sa conception, à un effort constant d’argumentation des choix méthodologiques retenus et, enfin, à une interprétation étoffée des résultats produits.
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AFCROs and EUCROF (EUROPEAN CRO Federation) Executive Boards are pleased to announce that Vicki Iassonidou (AFCROs & PRA Health Services) has been selected and approved by the EMA to become EUCROF’s second Product Owner (PO), following conclusion of a recent selection process. Vicki, in her PO role, will join the Sponsor PO team lead by Pierre Omnes and including Lydia Domingues, who also acts as a PO on behalf of EUCROF.
These POs are playing a vital role in the development of the EMA’s Clinical Trial Information System (CTIS), which is a prerequisite to the implementation of the EU Clinical Trial Regulation. The CTIS is at a crucial stage of its development in the coming months, ahead of its audit, which is scheduled to start in December 2020.
Congratulations to Vicki for being selected as a PO and please join EUCROF’s Executive Board in wishing Vicki every success in her new role.
If you have any questions then please send an email on info@eucrof.eu
The EMA issued its first Clinical Trials Information System newsletter “CTIS Highlights”, which will be published twice a year. The newsletter will provide you with insights on the development of CTIS. The EMA believes that the information it provides will be interesting and useful for your work. For more information click HERE.
Retrouvez dans chaque numéro de la revue spécialisée DeviceMed, l’article rédigé par les membres du groupe de travail Dispositif Médical :
Numéro juillet-août 2020
La crise sanitaire de la COVID-19 a placé la recherche clinique sous les feux de l’actualité.
Sara Sohier et Odile Capronnier vous proposent de revenir sur ses notions clés et ses principaux enjeux, en ce qui concerne plus particulièrement le dispositif médical.
Pour lire les articles précédents cliquez ici
