mindsON RBQM | Special Edition: Risk-Based Medical Monitoring Under ICH E6(R3) – Supporting Patient Safety with Technology
Get ready for a focused mindsON session exploring how the new ICH E6(R3) guideline reshapes Risk-Based Medical Monitoring. Clinical trial teams are now expected to adopt a more structured approach to patient safety, risk management, and data oversight. This session reveals how AI-powered tools can simplify the expanded responsibilities of medical monitors, pharmacovigilance teams, clinical operations, and data managers.
Key Topics:
• ICH E6(R3) Guidelines: Understand the latest expectations in protocol compliance, safety oversight, and risk-based quality management for clinical trials.
• Practical Approaches to New Requirements: Discover practical strategies to manage monitoring activities across different trial phases effectively and efficiently.
• Technology in Action: See how a digital Subject Profiles tool enables centralized monitoring, improves workflow, and supports early detection of safety risks.
What You’ll Learn:
Medical Monitors, Clinical Operations Managers, Data Managers, Pharmacovigilance Specialists, Quality Assurance Professionals, CRO Teams, and anyone responsible for patient safety and regulatory compliance in clinical trials.
