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Clinical Trials Information System (CTIS) bitesize talk: Transitional trials and additional Member State concerned (MSC) application, Amsterdam

datum 23 juni 2022
plaats Amsterdam
organisatie Europees Geneesmiddelenagentschap (EMA)

CTIS is the business tool of the EU Clinical Trials Regulation (Regulation (EU) No 536/2014) and itacts as a single entry point for clinical trial authorisation and supervision in the European Economic Area.This bitesize talk on CTIS provides an opportunity for sponsors to learn how to create and submit transitional trials and also how to submit an additional Member State concerned (MSC) application in Clinical Trials Information System (CTIS). Sponsors will also have opportunity to ask questions on these CTIS topics during the event.The event is open to all sponsor organisations, including pharmaceutical companies, contract research organisations, small and medium-sized enterprises (SMEs) and academic organisations. EMA cannot provide attendees certificates of attendance for this event.To be better prepared for this event, sponsors are encouraged to consult the CTIS training and support materials, including the CTIS sponsor handbook and the online modular training programme focusing on Module 23 (Transitional trials) and Module 10 (Create, submit and withdraw a clinical trial). Event will be live broadcast and no registration is required for those wishing to follow the live broadcast on EMA’s website.A video recording is made available after the event. Processing and publication of the video recording typically takes up to 60 days. Please subscribe to the clinical trials newsletter for updates on the availability of CTIS event video recordings.



Europees Geneesmiddelenagentschap (EMA)

Dit agentschap houdt toezicht op de kwaliteit van geneesmiddelen voor mens en dier binnen de EU. Het coördineert de beoordeling en bewaking van geneesmiddelen in de EU. Sinds 2022 houdt het agentschap zich ook bezig met het opsporen en voorkomen van medicijntekorten en medische hulpmiddelen in de EU.


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