Clinical Trials Information System (CTIS) bitesize talk: IMPD-Q only submission
CTIS is the business tool of the EU Clinical Trials Regulation (Regulation (EU) No 536/2014) and it acts as a single entry point for clinical trial authorisation and supervision in the European Economic Area.
This bitesize talk will focus on part I-only submission of the investigational medicinal product dossier on quality (IMPD-Q), and related scenarios.
Sponsors will also be able to ask questions on this CTIS topic during the event.
To be better prepared for this event, sponsors are encouraged to consult the CTIS training and support materials and question and answer 2.15 from Clinical Trials Regulation (EU) no 536/2014 - Questions and answers - volume 10 - Guidance documents applying to clinical trials.
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 participants with certificates of attendance for this event.
CTIS Bitesize talks are 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 take up to 60 days. Please subscribe to the Clinical Trials highlights newsletter for updates on the availability of CTIS event video recordings.
Participants can ask questions 2 weeks in advance of the event start date, and during the event via the audience interaction tool Slido.
Please go to www.sli.do and enter the event code '#bt10may'.
Interaction via Slido is voluntary, and you may opt to remain anonymous. If you choose to use Slido, you consent to process your personal data as explained in the EMA Data Privacy Statement for Slido.