3

The ICR Ethics and GCP Forum provides an excellent opportunity to:

•  Keep up to date with current ethical and clinical research issues
• Learn about new industry and regulatory initiatives
• Hear key industry figures speak about their specialist fields
• Network with fellow clinical research professionals

Agenda

09:30    Online Registration/Dial-in

10:00    Welcome       

 Ethics Forum

10:15    MHRA Update

Kirsty Wydenbach, Deputy Unit Manager / Expert Medical Assessor, MHRA Clinical Trials Unit

11:00    Pause

11:10    Update on HRA Activity

Jen Harrison, HRA Approval Change Manager

12:10    Pause

12:20    Remote Consent – Ethical considerations

Dr Simon Kolstoe, Reader in Bioethics & University Ethics Advisor,University of Portsmouth, UK

13:05    Lunch Break 

  GCP Forum – New Ways of Working

14:00      Devices Update – post Regulation implementation and UK position

Keith Summerhayes, MDCRQ Solutions Ltd

14:45    Pause

14.55     NIHR Collaboration across the NHS, Social Care and  Research Study Teams 

 Lorraine Fincham, Commercial Research Initiative Manager, CRN National Coordinating Centre (CRNCC), NIHR Clinical Research Network (CRN)

15:40     Pause

15.50    Key GCP Updates

A summary of changes in GCP-related regulations and guidelines since the last Ethics/GCP Forum meeting

GCP Steering Committee

Ethics Forum Chair: Joan Perou

GCP Forum Steering Committee:

• Janice Hedgecock,
• Stuart Harris,
• Julia DeCesare
• Heidi Chandler
• Helen Buck
  
  

UCL Joint Research Office: Helen Cadiou