Dr Finnuala Lonsdale (Director, Human Products Authorisation and Registration) will introduce the day and present on the clinical trial landscape in Ireland from a HPRA perspective. 

This session will be hosted by the HPRA Clinical Trial Assessors, it will focus on providing information and advice for sponsors to consider for their clinical trial submissions. Topics covered will include regulatory advice, protocol advice, safety reporting requirements and a section on the IMPD-Q aspects.

Topics covered will include information on CTIS requirements, protocol design considerations, scientific aspects, safety reporting processes, amoung others.  There will also be an opportunity for attendees to ask questions. 

Topics covered will include information on the approach to quality assessment for clinical trials, common issues that arise during the assessment procedure and details on the IMPD-Q only approach, the session will also include a Q&A

An update on the COMBINE Pilot ‘All-in-one coordinated assessment’ which is offering an opportunity to test the feasibility of a coordinated approach to the assessment of combined studies (clinical trials involving performance studies) and is being co-led by the HPRA.  

This session will include an overview of the National Office and the NRECs.  There will be an update on the work of the NRECs and insights into ethical considerations encountered as part of clinical trial review.  

Chair: Anne Hayes, Inspections Manager, Compliance  

This session will be hosted by the HPRA GCP Inspectors and Compliance department. It will focus on the recent updates to GCP E6R3 and provide information and advice for sponsors and clinical trial sites. 

• Risk-based and proportionate approaches to the conduct of trials
• Data governance in clinical trials
• Serious breach management
• Updates to the registration of Processes under Article 61(5) of the Clinical Trial Regulation 

Wrap up and final questions