The AEMPS organizes an information session to facilitate the transition to the new Regulation of Clinical Trials and the CTIS System
The conference will be held on March 9, starting at 10:30 a.m., and requires prior registration
The objective of the session will focus on reporting on the new features implemented and resolving any doubts that may arise, in order to facilitate the transition to this stage.
On January 31, the CTIS System became the only channel for applications for clinical drug trials, both in the European Union (EU) and in the European Economic Area (EEA), in compliance with the new European Regulation of Clinical Trials.
With the aim of facilitating the transition to this new stage for all stakeholders, the Spanish Agency for Medicines and Health Products (AEMPS) will hold the next March 9. the informative day online "New European regulation of clinical trials and full application of CTIS". The session will include the participation of the director of the AEMPS, María Jesús Lamas, and experts from the Agency's Clinical Trials Area.
One of the purposes of this conference is to create a space for the resolution of doubts about the changes recently implemented in the field of clinical trials. For this, after the interventions of the AEMPS experts, the questions raised by the attendees will be resolved.
This activity is aimed, fundamentally, at the pharmaceutical industry, CEIm members, researchers, public bodies and other groups interested in the regulation and processing of clinical trials.
Pre-registration is required to attend the conference, for this reason a form on the AEMPS website. Likewise, in keeping with the purpose of this informative session to resolve any doubts that may arise, said form raises the possibility for registered persons to previously ask questions about the matter to be dealt with.
