The trend of global clinical trials - Implications of ICH E17

Inger Mollerup

doi:10.1254/jpssuppl.WCP2018.0_SY34-4

WCP2018 (The 18th World Congress of Basic and Clinical Pharmacology)

Session ID : WCP2018_SY34-4

DOI https://doi.org/10.1254/jpssuppl.WCP2018.0_SY34-4

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Host: The Japanese Pharmacological Society, The Japanese Society of Clinical Pharmacology

Name : WCP2018 (18th World Congress of Basic and Clinical Pharmacology)

Location : Kyoto

Date : July 01, 2018 - July 06, 2018

Symposium

The trend of global clinical trials - Implications of ICH E17

Inger Mollerup

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Keywords: Multiregional clinical trials, ICH E17

CONFERENCE PROCEEDINGS OPEN ACCESS

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Abstract

The ICH E17 guideline, General Principles for Planning and Design of Multi-Regional Clinical Trials, has passed Step 4 and thereby has entered the implementation phase .

This is a very important guideline for clinical trials moving forward. The key principles in the guideline and implications for planning multiregional clinical trials (including ethnic factors) will be discussed.

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