ONLINE via Zoom - Zoom link will be sent out prior to the meeting.
The ICR Ethics & GCP Forum is the ICR's flagship event for Industry and Academia alike, and it has been running for over 20 years. The forum has a dedicated volunteer committee who plan the content and recruit the speakers, which includes regular speakers with hot off the press topics from the HRA, NIHR and the MHRA. Each forum closes with an up to the minute summary of the changes that have or will be taking place. The Forum is held twice a year, once in Spring face-to-face and the second in Autumn, currently virtually.
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Fee: £45 for members, £60 for non-members
9.30 - Zoom open for log-in
9.35 - Welcome from the ICR Board of Directors - Introductions and current status
9.50 - Welcome from the Ethics & GCP Forum Committee - Introduction to new members
10.00 - Innovative Devices Access Pathway (IDAP set to support safe patient access to innovative medical technologies
Penny Wilson - Deputy Director, Healthcare Quality and Access, MHRA
Penny joined the MHRA in June 2022, having been seconded from Innovate UK to DHSC and UKHSA as a Lead Scientific Advisor in the Technology Validation Group. Penny worked for over 25 years in the diagnostics industry in a number of senior and strategy roles.
10.45 - Clinical trials – Update and getting back on track (including Lord O’Shaughnessy report and Pro-innovation review (McLean life sciences review)) plus CT regulation. Supporting future innovation – ILAP, scientific advice
Kirsty Wydenbach - Head of Regulatory Strategy at Weatherden
Dr Kirsty Wydenbach is part of a consultancy experienced in supporting preclinical and clinical stage companies to de-risk drug development. Prior to this, she had over 13 years' experience as an Expert Medical Assessor at the MHRA within the Clinical Trials Unit.
11.30 - HRA Update
Jen Harrison- Change Manager HRA
Jen Harrison supports researchers, sponsors and NHS sites with the implementation of system, process, and policy changes, listening to feedback and resolving issues and inconsistencies for study set up. She also has Regulatory Affairs and Research Governance Manager experience.
12.15 - Break
13.00 - Using the voice of participant experience to optimise ATMP trials in neurodegenerative disease.
Cheney Drew, Senior Research Fellow and Deputy Director of Brain Health and Mental Wellbeing Trials. Centre for Trials Research, Cardiff University
Cheney Drew is involved in the development and delivery of trials aimed at evaluating interventions in people with Huntington's disease and other neurological disorders with a focus on how participants are approached, informed and provide consent to involvement in these trials.
13.45 - Equality, Diversity and Inclusivity in Clinical Trials
Poonam Palan, Equality, Diversity and Inclusion Co-ordinator Great Ormond Street Hospital/UCL Institute of Child Health
Poonam works across UCL Great Ormond Street Institute of Child Health and the NIHR GOSH Biomedical Research Centre supporting all EDI activities and developing EDI strategies.
14.30 - Key GCP Updates
A summary of changes in GCP-related regulations and guidelines since the last Ethics/GCP Forum meeting
Jo Burmester, Director, Clinical Trial Know-How
Jo Burmester is a very experienced Clinical Research Training Consultant who has provided GCP expertise to the Clinical Research Community for more years than she likes to admit to in writing.
15.15 - Final Proceedings and Date for Next In-Person Forum
Helen Buck and Trish Parry, Co-Chairs of the ICR Ethics and GCP Forum
*(This agenda is subject to change)