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

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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. 

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This is a query that is routinely being asked by risk management professionals across industries.  How does an organization mitigate risk?  Risk, the dreaded possibility that something bad or unpleasant will happen.  The challenge we face in drug development is that, in many instances, we appear to be managing issues rather than risks.  Why is this so prevalent?  For one, it is sometimes easier to address a problem when it drops in front of us rather than trying to figure out the possibility that a problem will occur, the impact it could have, the resources it might take to address, and more.  Risk mitigation planning is a thoughtful, time-consuming process that requires resources.  And, as we heard earlier this year at our Avoca Quality Consortium (AQC) Summits, time/resources are a scathing challenge for drug development professionals.

The good news?  Drug development professionals know that firefighting is not a sustainable way to operate in a journey that continues to get more challenging and expensive with each passing day.  I saw this recognition and enthusiasm for change firsthand in the over 200 attendees that listened and engaged in a recent webinar entitled, “Utilizing Proactive Risk Management Mapping as an Effective Clinical Oversight Process and Tool.”  These attendees wanted to know more, asked about tools, enquired about processes, all in the interest of embracing a thoughtful way to manage risk rather than continue with the daily firefighting.

Here are some of the top-of-mind questions I heard from attendees:  Risk Mapping Webinar Q&A

If you are curious to hear the discussion in detail, you can access a recording of this webinar here:  Risk Mapping Webinar

Oh, and right as I completed this post, I happened to talk to two AQC members who are leading a seamless multidisciplinary partnership across GxPs to mitigate risk proactively and have success stories to tell.  Very encouraging indeed!

Where is your organization in this journey?  Do you believe that firefighting as a culture needs to change?  What’s standing in the way of this change?  I’d love to hear your thoughts/debates.

Until next time………

Lakshmi

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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. 

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