ICH E6(R3) Risk Management and Oversight: A Priority Update for Sponsors
ICH E6(R3) introduces new expectations for oversight, data integrity, and quality. Sponsors now face pressure to prioritize process updates so their teams don’t waste time or miss critical risks.
At Beyond Clinical Compliance, on September 9th in Philadelphia, Donna Dorozinsky addressed this challenge in her session:
“Aligning Processes with R3: How to Prioritize Updates So Your Clinical Team Doesn’t Waste Time or Miss Critical Risks.”
Donna broke her talk into three priority process areas where sponsors must act:
Risk Management & Oversight
Data Integrity & Technology Governance
QbD & Continuous Improvement
This short clip focuses on the first area — Risk Management and Oversight. Donna highlights why regulators expect proactive, documented oversight and why missing or informal processes can quickly lead to critical findings.
👉 Watch the 4-minute clip below:
From the session
R3 requires documented, proactive risk oversight — not informal processes.
Records like risk logs, breach documentation, and remediation evidence are non-negotiable.
Sponsors need integrated workflows: Risk Identification → Action → Follow-Up Evidence.
This clip is only one piece of Donna’s full presentation. Stay tuned for upcoming clips on the other two process areas: Data Integrity & Technology Governance and QbD & Continuous Improvement.
