Abstract

ICH E6 R2 Addendum : Impact on India

Arun Bhatt, Consultant, Clinical Research & Development

ICH E6 – good clinical practice (GCP) (R2) addendum was released in 2016 to encourage implementation of improved approaches for management of clinical trials. The changes in different sections include new approaches – Quality Management System (QMS), Risk-based monitoring (RBM) - with emphasis on human subject protection and data integrity. These changes will create major challenges in adoption and implementation for clinical trial stakeholders especially for the sponsors. Adoption and implementation of ICH E6(R2) guideline will require major changes in all areas – quality systems, SOPs, technology, team, training – and at all levels – organization, investigator, sites, CROs, vendors.  Adoption and implementation of ICH E6(R2) will require an attitudinal shift for the pharma company sponsors.