ICH E6 (R2) is top of mind

Posted in Regulatory, Risk Mitigation

1996 – A year on the calendar which was punctuated with a number of firsts – DVDs were launched, the first mammal was cloned, eBay debuted as one of the hottest companies and closer to our space, the adoption of ICH E6 GCP became a reality. Oh and may I add that Google did not exist in 1996!  Fast forward to 2017 and we are living in an age of change brought upon by unprecedented access/connectivity.   For the first time in 20 years, the ICH E6 GCP guidelines have adopted a new revision, brought upon by the impact of globalization, complexity, and technological advancement in clinical trials.

The striking change is the spirit in which the new set of guidelines is encouraging a shift in mind set in managing quality in clinical trials. ICH E6 (R2) is calling upon legions of drug development professionals to recognize that all risks are not of equal importance from a compliance and quality perspective and the key to effectively achieving quality is through making key decisions based on a careful assessment of risk.

Risk, a term that usually tends to invoke shudders because it is all about the “possibility that something can go wrong” is now omnipresent in quality management.  Risk based approaches to oversight, monitoring, inspections and more are the new normal.

There is a lot of frenzy around understanding the guidelines.  There are a lot of processes being put in place to make sure that ICH E6 (R2) is kept at the forefront of the way clinical trial processes evolve.  My question is this.  How are organizations getting their teams to change their mindset?  As far as I can remember, the words quality and compliance were at the heart of decisions.  How does one get employees to talk about and manage risk?

Since the launch of our Avoca Quality Consortium (AQC) five years ago, we have been working with our Members to prepare for this changing environment through the raising of awareness, cross-industry dialogue and the development of proactive, tool based approaches to managing quality.  Our Members believe that the best way to approach this change is to get the conversations flowing, not just within companies, but across the clinical trial ecosystem.

At our recent AQC Member meeting with executives, we heard loud and clear that the industry is mobilizing resources to understand and respond to the new guidelines.  This is now on top of our initiatives for 2017 where we will help our Member companies to understand the implications of ICH E6 (R2), guide them with leading practices and develop tools to respond and stay ahead.

We’d love to hear your thoughts on where you are in your journey in this risk based world of quality management.

Until next time………


Lakshmi Sundar has spent two decades in the pharmaceutical industry, leading teams across sponsors and CROs in multiple functional areas to spark innovation, manage risk, and lead change with a sense of purpose and fun. At Avoca, Lakshmi partners with members of the Avoca Quality Consortium and industry innovators to deepen the dialogue on building a quality culture within and across organizations to mitigate risk, advance drug development, and bring treatments to patients in a more effective manner.