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20 November 2019

Chrissie Fletcher

This session covers an overview of ICH E17 (General Principles for Planning and Design of Multi-Regional Clinical Trials). This Guideline provides guidance on general principles on planning/designing Multi-Regional Clinical Trial (MRCT). Drug development has been globalised and MRCT for regulatory submission has widely been conducted in ICH regions and beyond. Regulatory agencies are currently facing some challenges in evaluating data from MRCTs for drug approval and it was deemed necessary to developed a Harmonised international Guideline to promote conducting MRCT appropriately, especially focusing on scientific issues in planning/designing MRCTs. This Guideline complements the guidance on MRCTs provided in ICH E5(R1) Guideline and facilitates MRCT data acceptance by multiple regulatory agencies.

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