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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

  • Regulatory Science
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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.

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References

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Authors and Affiliations

  1. Division of Epidemiology, Office of Safety I, Pharmaceuticals and Medical Devices Agency, Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyodaku, Tokyo, 100-0013, Japan

    Yoshiaki Uyama PhD, Eriko Yamazaki MS & Tomoko Osawa PhD

  2. Department of Health, Therapeutic Goods Administration, Woden, Australia

    Katherine Clark BSc(Hons) PhD

  3. Food and Drug Administration, Taipei, Taiwan

    Chao-Yi Wang MSc

  4. The National Agency of Drug and Food Control, Jakarta Pusat, Indonesia

    Endang Woro MSc

  5. Health Sciences Authority, Singapore, Singapore

    Foo Yang Tong BSc(Pharm) & Sumitra Sachidanandan BSc(Pharm)(Hons)

  6. European Medicines Agency, London, UK

    Ana Rodriguez PhD

  7. Ministry of Food and Drug Safety, Cheongju, Korea

    Hojin Oh PharmD

  8. National Pharmaceutical Control Bureau, Ministry of Health Selangor Darul Ehsan, Selangor, Malaysia

    Kamaruzaman Saleh BPharm(Hons), MSc, PhD

  9. Food and Drug Administration, Muntinlupa City, Philippines

    Joyce Cirunay

  10. Food and Drug Administration, Nonthaburi, Thailand

    Akanid Wapeewuttikorn BSc(Pharm), MSPH(Epidemiology)

  11. Federal Service on Surveillance in Healthcare and Social Development (Roszdravnadzor), Moscow, Russia

    Evgeny Rogov MD, PhD, JD

  12. Saudi Food and Drug Authority, Riyadh, Saudi Arabia

    Khaled W. Alshahwan MPharm

  13. Ministry of Health, San José, Costa Rica

    Ileana Herrera MD

  14. Southern African Development Community Secretariat, Gaborone, Botswana

    Joseph Mthetwa BSc(Pharm)(Hons), MSc(Med), DClinMed, AD Edu

  15. Ministry of Health, Matsapha, Swaziland

    Fortunate Fakudze BSc, BPharm(Hons)

Authors
  1. Yoshiaki Uyama PhD
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  2. Eriko Yamazaki MS
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  3. Katherine Clark BSc(Hons) PhD
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  4. Chao-Yi Wang MSc
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  5. Endang Woro MSc
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  6. Foo Yang Tong BSc(Pharm)
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  7. Sumitra Sachidanandan BSc(Pharm)(Hons)
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  8. Ana Rodriguez PhD
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  9. Hojin Oh PharmD
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  10. Kamaruzaman Saleh BPharm(Hons), MSc, PhD
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  11. Joyce Cirunay
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  12. Akanid Wapeewuttikorn BSc(Pharm), MSPH(Epidemiology)
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  13. Evgeny Rogov MD, PhD, JD
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  14. Khaled W. Alshahwan MPharm
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  15. Ileana Herrera MD
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  16. Joseph Mthetwa BSc(Pharm)(Hons), MSc(Med), DClinMed, AD Edu
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  17. Fortunate Fakudze BSc, BPharm(Hons)
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  18. Tomoko Osawa PhD
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Consortia

E6 Discussion Group under the International Pharmaceutical Regulators Forum

Corresponding author

Correspondence to Yoshiaki Uyama PhD.

Additional information

Author Note

The views expressed in this manuscript are the personal views of the authors and do not necessarily reflect the official views of the respective regulatory agencies.

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Uyama, Y., Yamazaki, E., Clark, K. et al. 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 49, 249–253 (2015). https://doi.org/10.1177/2168479014551646

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  • DOI: https://doi.org/10.1177/2168479014551646

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