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General Principles for the Education and Training of GCP Inspectors: The Outcome of Discussions by International Regulatory Experts in the Discussion Group on the ICH E6 Guideline.
General Principles for the Education and Training of GCP Inspectors: The Outcome of Discussions by International Regulatory Experts in the Discussion Group on the ICH E6 Guideline.
- Source :
- Therapeutic Innovation & Regulatory Science; Mar2015, Vol. 49 Issue 2, p249-253, 5p
- Publication Year :
- 2015
-
Abstract
- The article provides a summary of the background and past activities of the E6 Discussion Group established under the International Pharmaceutical Regulators Forum. Topics discusses include the establishment of the Regulators Forum to create a regulator-only environment, the development of a statement on general principles for the training and education of Good Clinical Practice (GCP) inspectors which will serve as a reference to regulatory agencies.
- Subjects :
- EVALUATION of clinical trials
MEDICAL protocols
GOVERNMENT regulation
Subjects
Details
- Language :
- English
- ISSN :
- 21684790
- Volume :
- 49
- Issue :
- 2
- Database :
- Supplemental Index
- Journal :
- Therapeutic Innovation & Regulatory Science
- Publication Type :
- Academic Journal
- Accession number :
- 101215016
- Full Text :
- https://doi.org/10.1177/2168479014551646