Mind the Gaps: What Sponsors and CROs Aren’t Doing to Meet ICH E6 R3

Join us for a dynamic fireside-style chat exploring the critical gaps in how Sponsors and CROs are implementing the evolving requirements of ICH E6 R3. This 45–50 minute session will focus on three key areas—Risk-Based Approach (RBA), Quality by Design (QbD), and Computer Software Validation (CSV/CSA)—and uncover what’s being missed, misunderstood, or underutilized.

Expect a candid conversation driven by two industry experts. The conversation will also be driven by audience input. We’ll dive into real-world challenges, share insights, and explore practical strategies for addressing ICH E6 R3. We are hoping for an interactive audience that will gauge where the industry stands and spark deeper discussion around these three key areas of the guidelines. Bring your questions and share how you are tackling the gaps.

Presenter: Dawn Niccum, Executive Vice President of QA at inSeption Group

Dawn is the Executive Vice President of QA at inSeption Group, where she is responsible for and does consulting in all quality areas including SOP development, Deviation & CAPA management, oversight of the implementation and validation for systems used in clinical trials, audit conduct and support, and GCP training. Dawn has worked in the pharmaceutical industry and with clinical trials for more than 30 years. Dawn is a Steering Committee Member for the CDISC TMF Reference Model, Chair of the Educational Governance Committee, and is a Steering Committee Liaison for the ISF Reference Model initiative. She has presented as an SME at numerous conferences on clinical quality systems and inspection readiness.

Presenter: Marion Mays, CEO/Principal Consultant, Jerion Consulting Group

Marion is a dynamic, inspirational leader in the Life Sciences space with over 30 years of experience. Focusing on supporting Clinical Trials, especially around clinical records, and compliance. Well known in the industry for experience with Inspection Readiness, a trusted advisor to sponsors in support of regulatory inspections and activities to become inspection prepared. Marion’s background offers a unique combination of both strategic and operational abilities combined with creative thinking. Marion’s experience working for sponsors, CROs, and software vendors makes her uniquely positioned to offer valuable insights into the Clinical Research compliance process and implementing software in a regulated environment.