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

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

doi:10.1177/2168479014551646

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

Ther Innov Regul Sci. 2015 Mar;49(2):249-253. doi: 10.1177/2168479014551646.

Authors

Yoshiaki Uyama¹, Eriko Yamazaki¹, Katherine Clark², Chao-Yi Wang³, Endang Woro⁴, Foo Yang Tong⁵, Sumitra Sachidanandan⁵, Ana Rodriguez⁶, Hojin Oh⁷, Kamaruzaman Saleh⁸, Joyce Cirunay⁹, Akanid Wapeewuttikorn¹⁰, Evgeny Rogov¹¹, Khaled W Alshahwan¹², Ileana Herrera¹³, Joseph Mthetwa¹⁴, Fortunate Fakudze¹⁵, Tomoko Osawa¹

Affiliations

¹ 1 Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
² 2 Therapeutic Goods Administration, Department of Health, Woden, Australia.
³ 3 Food and Drug Administration, Taiwan, Chinese Taipei.
⁴ 4 The National Agency of Drug and Food Control, Jakarta Pusat, Indonesia.
⁵ 5 Health Sciences Authority, Singapore.
⁶ 6 European Medicines Agency, London, UK.
⁷ 7 Ministry of Food and Drug Safety, Cheongju, Korea.
⁸ 8 National Pharmaceutical Control Bureau, Ministry of Health Selangor Darul Ehsan, Malaysia.
⁹ 9 Food and Drug Administration, Muntinlupa City, Philippines.
¹⁰ 10 Food and Drug Administration, Nonthaburi, Thailand.
¹¹ 11 Federal Service on Surveillance in Healthcare and Social Development (Roszdravnadzor), Moscow, Russia.
¹² 12 Saudi Food and Drug Authority, Riyadh, Saudi Arabia.
¹³ 13 Ministry of Health, San José, Costa Rica.
¹⁴ 14 Southern African Development Community Secretariat, Gaborone, Botswana.
¹⁵ 15 Ministry of Health, Matsapha, Swaziland.

PMID: 30222411
DOI: 10.1177/2168479014551646

Abstract

In response to the globalization of drug development, regulatory inspection of Good Clinical Practice (GCP) has recently been conducted not only by International Conference on Harmonisation (ICH) regions but also non-ICH regions. To promote the international implementation of GCP, consistent understanding and interpretation of its concept among regions are important. This article summarizes the background and past activities of the E6 Discussion Group, established under the Regulators Forum.

Keywords: clinical trials; good clinical practice; harmonization; implementation; regulatory inspection.