As part of Health and Social Care Research & Development (HSC R&D) Division’s ongoing project management support services and activities in the area of European Union (EU), Northern Ireland Protocol (NIP) / Windsor Framework (WF) to the Health & Social Care NI Trusts (HSCNI), specifically around the project management of operational regulatory impacts and risks around clinical trials, HSC R&D Division (in conjunction with Department of Health NI) recently hosted a Health Engagement Session on Clinical Trial Regulatory Impact and Risk.
The purpose of the Health Engagement Session was to allow health representatives to have a voice and share their concerns and challenges around EU regulatory compliance, with constructive dialogue being exchanged between the attendees and panel.
The panel consisted of an expert delegation (from the Department of Health & Social Care (DHSC) and Medicines Healthcare products Regulatory Agency (MHRA)) to respond to an extensive range of questions and issues from HSCNI representatives attending.
Audience questions covered pertinent issues, problems and challenges currently encountered by HSCNI within medicines, medical devices and in vitro diagnostics, especially relating to ongoing operational difficulties around clinical trial sponsor compliance to EU regulations considering Northern Ireland’s unique position under the NIP/ WF.
For more information or should you have any questions, or have any operational regulatory compliance issues impacting HSCNI trusts due to EU/NIP/WF regulatory requirements, please contact Michael Graham by email: michael.graham@hscni.net