Save the date – the new Clinical Trial Regulation explained

Event Date: 22/11/2021 11:00 - 25/11/2021 12:00

The Clinical Trial Regulation will come into effect on 31 January 2022. The HPRA, in conjunction with the National Office for Research Ethics Committee, will hold a series of one–hour webinars from Monday 22 to Thursday 25 November to help stakeholders understand the new requirements. 

The webinars will cover topics such as an overview of the main differences between the Directive and the Regulation, including increased transparency requirements, as well as highlighting particular national aspects, such as the legal representative. Updates relating to safety reporting and compliance as well as guidance on next steps will also be presented.

Overall, the webinars aim to provide an update on the national framework for the Regulation and to present the main changes that those involved in clinical trials in Ireland can expect when the Regulation is implemented, and throughout the three-year transition period that will follow.  

Dates and times

The webinars will take place from 11 am to 12 pm from Monday 22 to Thursday 25 November.

Agenda and registration

Registration will open in late October / early November and a confirmed agenda will be available at that point. The information and a registration link will be added to this webpage.

Who should attend

Clinical trial sponsors should attend, including commercial and non-commercial / academic sponsors. 

Fee details

The webinars will be free of charge but advance registration will be required.

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