Current Edition

Implementation of ICH E6 R2 – An Overview of Key Changes

After release of the final draft of ICH E6 R2 in November 2016, the regulatory bodies started announcing the implementation of E6 R2 one after the other. This makes the sponsors and CROs look actively into implementing the new guidelines to their clinical studies. Ashok Ghone at MakroCare USA says that the changes in the guidelines are clear to understand but the challenging part is to change the mindset, culture and practice of traditional way of designing, planning and executing clinical trials, and take a more proactive risk-based quality management approach.