Event Date: 22/11/2021 11:00 - 25/11/2021 12:00
The Clinical Trial Regulation (Regulation No 536/2014) will come into effect on 31 January 2022. The HPRA, in conjunction with the National Office for Research Ethics Committees, held a series of one–hour webinars from Monday 22 to Thursday 25 November to help stakeholders understand the new requirements.
The webinars covered topics such as an overview of the Regulation, including post-authorisation and compliance aspects, and guidance on next steps for sponsors and investigators. The Department of Health will provide an update on the national framework for the Regulation.
The aim of the webinars is 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.
Video recordings and presentation slides from the webinars are available on the dedicated Clinical Trial Regulation page, under 'Webinars November 2021'.
Dates and times
The webinars took place from 11 am to 12 pm from Monday 22 to Thursday 25 November.
Who should attend?
Commercial and non-commercial/academic clinical trial sponsors and investigators should attend.
For information on the topics that will be covered during the webinar series, please download the agenda.
Registration for the webinars is now closed.
The webinars are free of charge but advance registration is required using the link available above.