Integrated addendum to ICH E6(R1): Guideline for good clinical practice E6(R2)

Published by International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)

Regulatory Authorities Internatonal Council for Harmonisation (ICH)

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) brings together the medicines regulatory authorities and pharmaceutical industry around the world.

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ICH E8 General considerations for Clinical Studies

Published by EMA International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)

Regulatory Authorities Internatonal Council for Harmonisation (ICH)

This document provides guidance on the clinical development lifecycle, including designing quality into Clinical Studies, considering the broad range of clinical study designs and data sources used

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Integrated addendum to ICH E6(R1): Guideline for good clinical practice E6(R2)

ICH E8 General considerations for Clinical Studies

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