Andrew Fisher

ICH E6 (R3) Good Clinical Practice

Andrew Fisher, 26 May 2023 - Good clinical practice, Inside the Inspectorate, Wider MHRA

As a Lead Senior GCP Inspector at the UK Medicines and Healthcare products Regulatory Agency (MHRA), I thought it would be useful to write about the changes to the International Council for Harmonisation (ICH) E6 Good Clinical Practice (GCP) Guideline …

ICH E6(R3) Good Clinical Practice guidance - Step 2 Public Consultation

Andrew Fisher and Jason Wakelin-Smith, 2 May 2023 - Good clinical practice, Uncategorized

The International Council for Harmonisation (ICH) Expert Working Group for ICH E6(R3) (EWG) has been updating the ICH E6(R2) Good Clinical Practice (GCP) guideline. The E6(R3) overarching principles, Annex 1, Glossary and 3 Appendices will replace the current E6(R2). These …

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