mindsON RBQM | Special Edition: Change: Why 70% fail and how to succeed in Risk Management
The draft ICH E6 (R3) guidelines strongly emphasize Risk Management across clinical trials – from monitoring to quality oversight and data integrity. Whilst industry data shows 90% adoption of risk assessments, there is only 50% adoption of KRIs and 25% adoption of QTLs (required since 2016). While the need for change is clear, successfully implementing these changes remains challenging. Research shows that up to 70% of change initiatives fail due to resistance, unclear processes, and cultural misalignment.
In this highly interactive webinar, Keith Dorricott & Raik Knieknecht will share real-world insights and proven strategies for driving successful transformation in accordance with the new ICH E6 (R3) requirements. Participants will learn how to manage resistance, align teams, and build a sustainable framework for Risk Management across clinical operations.
What to Expect:
- Why Change Fails: Explore common barriers to implementing Risk Management under ICH E6 (R3), including resistance to change, unclear roles, and lack of engagement.
- Real-World Insights: Learn from practical examples of successful (and failed) transformations in clinical trial settings.
- Interactive Discussions: Share experiences and challenges with peers to identify actionable solutions.
- Practical Strategies: Discover clear, structured approaches to integrate Risk Management across processes, teams, and systems.
Key Takeaways:
- Understand the critical requirements of ICH E6 (R3) regarding Risk Management
- Identify typical challenges and strategies to overcome them during change initiatives
- Gain tools to lead change effectively, from employee engagement to cultural alignment
Who Should Attend:
This webinar is ideal for clinical trial leaders, project managers, QA professionals, and anyone who implements ICH E6 (R3) requirements and drives change within their organizations.
Join us and learn how to turn Risk Management challenges into opportunities for success under ICH E6 (R3).
