Tiedoksi EMA:n koulutukset:
Two upcoming on-line events hosted by EMA with relation to the release of CTIS:
* October 26th 2021: Clinical Trials Information System (CTIS): Virtual information day The aim of this event is to help future CTIS users prepare for submitting and evaluating clinical trial applications in CTIS after its go-live on 31 January 2022.
This event will present a high-level overview of CTIS and there will take place a live demonstration of the system's restricted workspaces. It will also present the future user’s perspective on preparing for CTIS go-live. This is event is aimed at clinical trialhttps://www.ema.europa.eu/en/glossary/clinical-trial sponsors and contract research organisations (CROs). For more information and registration details please see event’s webpage: Clinical Trials Information System (CTIS): Virtual information day | European Medicines Agency (europa.eu)https://www.ema.europa.eu/en/events/clinical-trials-information-system-ctis-virtual-information-day
* November 29th 2021: Webinar for small and medium-sized enterprises (SMEs) and academia on the Clinical Trials Regulation and the Clinical Trials Information System (CTIS) This event aims to inform SMEs and academic sponsors of clinical trials on how to prepare for the main changes brought by the Regulation and its impact on their trial-related activities.
Topics include an overview of CTIS functionalities (also transparency aspects and safety reporting requirements), as well as guidance and training material available for sponsors. For more information and registration details please see event’s webpage: Webinar for small and medium-sized enterprises (SMEs) and academia on the Clinical Trials Regulation and the Clinical Trials Information System (CTIS) | European Medicines Agency (europa.eu)https://www.ema.europa.eu/en/events/webinar-small-medium-sized-enterprises-smes-academia-clinical-trials-regulation-clinical-trials