HPRA Clinical Trials Information Day - Save the date

The HPRA would like to invite clinical trial stakeholders to save the date for an upcoming Clinical Trial Information Day.

Date 

November 12, 2025 

Time

9:30am - 4pm (Registration open from 8.30am) 

Location

Hilton Hotel - Charlemont Place, Saint Kevin's, Dublin, D02 A893

This event is intended to be an informative session that will be of interest to commercial and non-commercial sponsors and clinical trial site staff.

Agenda topics will include: 

• Clinical trial application advice
• Safety assessment in clinical trials
• Updates on the COMBINE ‘All-in-one’ pilot
• Updates from the National Research Ethics Committee
• Data governance in clinical trials
• Risk-based and proportionate approaches to the conduct of clinical trials
• Serious breach management
• Updates to the registration of Processes under Article 61(5) of the Clinical Trial Regulation

There will also be opportunities to ask questions.

A more detailed agenda will be published when the registration for the event opens in mid-September.