Source: WUTH Research and Development
For fulltext link here
Date of publication: August 2009
In a nutshell: WUTH employed researchers should attend GCP training every 18 months, with a maximum of two years between training as a limit.
The next GCP training session is as follows:
*Research Governance & ICH-GCP Training for Researchers
*Accredited by the Royal College of Physicians
*Education Centre, Arrowe Park Hospital
*Friday 11th September 13.00-16.00 pm
*To book your place, please ring the R&D/CTU Office Ext 2958 or by email to Carol.Eames@whnt.nhs.uk
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).
Some important notes:
GCP: Good Clinical Practice - 'Design, conduct, performance, monitoring,auditing, recording, analysis and reporting of clinical trials and toensure the rights, integrity and confidentiality of trial subjects are protected'
ICH: International Conference on Harmonisation (of technical requirementsfor registrationof pharmaceutical products for human use)
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