Reflections on ExL's 10th Proactive GCP Summit.

By Megan Brickley, Consultant I

It has been just about a week since the ExL’s 10th Proactive GCP Compliance Conference, and I still feel as though I am processing the wealth of information I received. There was no shortage of experience at this event, with the room packed full of seasoned industry professionals representing the spectrum of large and small companies.

The conference focused on effective risk-based approaches for optimizing clinical quality and achieving inspection readiness. With the urgent shift on the focus of implementing ICH E6 R2, it was clear that conference attendees were hoping to better understand industry “best practices” to making this work within their organizations. 

Each day of the conference was full of great presentations and panels that really represented the gray and seemingly un-navigable areas of compliance for our industry today. The lineup of panels and presenters were overly willing to share what has worked and more importantly not worked for their organizations. The audience remained actively engaged throughout the conference, asking questions and participating in electronic polls throughout each presentation.

The presentations and panels were interactive, and became more conversational - which elicited great discussion and information sharing. The presenters and panelists were extremely captivating in taking a deeper dive into difficulties they have had in implementation of ICH E6 R2, and it became clear that in taking a risk-based approach and building quality in to programs from the start that “one size does not fit all.”

Outside of the conference room during networking breaks and roundtable discussions, collaboration between different company representatives continued and the willingness to support and share was overtly apparent.

The ExL conference was an amazing opportunity for our industry to come together and take positive steps in developing innovative approaches regarding the optimization of risk-based approaches and drive towards a constant state of inspection readiness.