|Date & Time||22 Feb & 4 Mar 2021 @13.30|
The way clinical trials are conducted in the EU will undergo a major change when the Clinical Trial Regulation (Regulation (EU) No 536/2014) comes into application. The Regulation harmonises the assessment and supervision processes for clinical trials throughout the EU, via a Clinical Trials Information System (CTIS). The Clinical Trials Regulation will become applicable as CTIS goes live, which is anticipated in December 2021. Once launched, CTIS will be immediately available for authorities and for clinical trial sponsors, while a three-year phased transition period from the current Directive 2001/20/EC to the Regulation will apply. To facilitate preparedness for use of CTIS users, the European Medicines Agency has developed a training programme to provide future CTIS users with the skills and knowledge to successfully use CTIS into their business. This training webinar provides essential information on CTIS for micro, small and medium-sized enterprises (SMEs) and non-commercial (academic) sponsors. For more information on CTIS, see Clinical Trial Regulation.
The first day of a two-part webinar will cover:
- Overview of CTIS
- User access management, including how to register users
- Sponsor user management
- Sponsor roles and permissions in CTIS
The second day of a two-day webinar will cover:
- Submitting an initial trial application in CTIS
- Updating an initial trial application, including making substantial modifications and adding a Member State concerned
- Making non-substantial modifications
- Submitting trial results
The webinar is free of charge for all attendees. More information on Day 1 can be found here and for Day 2 here.