16 de setembro de 2019

ICH NEWS: The ICH E17 Guideline training materials available now on the ICH website

From: www.ich.org

Drug development has been globalized 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 develop a harmonized international Guideline to promote conducting MRCT appropriately, especially focusing on scientific issues in planning/designing MRCTs. 

This new Guideline will complement the guidance on MRCTs provided in ICH E5(R1) Guideline and facilitate MRCT data acceptance by multiple regulatory agencies. 

An extensive set of training materials including 7 modules has been developed to promote the efficient and consistent implementation of the E17 Guideline in the context of an evolving drug development environment. 

The Training Materials for the 7 modules can be downloaded here.

Here you can watch a short video presenting basic principles about ICH E17, as well as giving an overview of all training materials available, making it easy to find information in the guidelines.