Source: Clinical Trials Unit, Arrowe Park Hospital http://www.whnt.nhs.uk/rd/default.aspx
Year of publication: 2009
Publication Type: Training opportunity
In a Nutshell: ICH-GCP Training (International Conference on Harmonisation - Good Clinical Practice) is available to Wirral University Teaching Hospital staff.
Date: Tuesday 9th June 2009
Time: 8.45 am to 12.15 pm
Venue: Lecture Theatre, Education Centre, Arrowe Park Hospital Wirral CH49 5PE
Cost: Free
Objective: To provide a clear understanding of why we have regulation of research; what that regulation (Research Governance) means in practice and, for the special case of clinical trials for licensing new drugs or devices, how to comply with the specific Regulatory Requirements (ICH-GCP). To book, contact carol.eames@whnt.nhs.uk.
Some important notes:
GCP (Good Clinical Practice) - 'Design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials and to ensure the rights, integrity and confidentiality of trial subjects are protected'.
ICH (International Conference on Harmonisation) (of technical requirements for registration of pharmaceutical products for human use).
