International Committee on Harmonisation (ICH) meeting 5th – 10th November 2016
ICH E6 (R2) update agreed and preparations in place for effective date of 14th June 2017. “Evolutions in technology and risk management processes offer new opportunities to increase efficiency and focus on relevant activities. When the original ICH E6(R1) text was prepared, clinical trials were performed in a largely paper-based process. Advances in use of electronic data recording and reporting facilitate implementation of other approaches. For example, centralized monitoring can now offer a greater advantage, to a broader range of trials than is suggested in the original text. Therefore, this guideline has been amended to encourage implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording and reporting while continuing to ensure human subject protection and reliability of trial results. Standards regarding electronic records and essential documents intended to increase clinical trial quality and efficiency have also been updated.”
Risk Management of processes, systems and data is addressed and includes Risk; Identification, evaluation, control, communication, review and reporting.
The full document can be located at - http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001251.jsp&mid=WC0b01ac0580032ec4
The committee also agreed to work on a new guideline ICH E19 which will aim to harmonise requirements on the optimal collection of safety data during late stage pre-market and post-approval clinical investigations of new drugs and new indications for approved drugs.