Guidance On Remote Gcp Inspections During The
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Guidance on remote GCP inspections during the COVID-19 ...
www.ema.europa.euGuidance on remote GCP inspections during the COVID-19 pandemic . This document is intended to provide guidance on the steps to be followed during remote good clinical practice (GCP) inspections. Adopted by GCP IWG . 18 May 2020 . Keywords . COVID-19, pandemic, GCP inspection, remote, virtual, distant, good
Reflections on the regulatory experience of remote ...
icmra.infoCovid-19 Working Group: Remote GCP and GMP Regulatory oversight inspections Final version 1.0 26 Nov 21 Page 1 of 15 Reflections on the regulatory experience of remote approaches to GCP and GMP regulatory oversight during the COVID-19 …
Guideline on the content, management and archiving of …
www.ema.europa.euGuideline (‘ICH GCP guideline’), regarding the structure, content, management and archiving of the clinical trial master file (TMF). The guidance also applies to the legal representatives and contract research organisation (CROs), which according to the ICH GCP guideline includes any third party such as