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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.

Authors :
Uyama, Yoshiaki
Yamazaki, Eriko
Clark, Katherine
Wang, Chao-Yi
Woro, Endang
Tong, Foo Yang
Sachidanandan, Sumitra
Rodriguez, Ana
Oh, Hojin
Saleh, Kamaruzaman
Cirunay, Joyce
Wapeewuttikorn, Akanid
Rogov, Evgeny
Alshahwan, Khaled W.
Herrera, Ileana
Mthetwa, Joseph
Fakudze, Fortunate
Osawa, Tomoko
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.

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