mindsON RBQM | Episode 34: Change - Why 70% fail and how to succeed in Risk Management

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February 19, 2025, 3:00 PM - 4:00 PM
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Moderators

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MyRBQM Academy by Cyntegrity

Targeted education helps clinical research teams embrace the implementation process and contribute to its success, ensuring your organization's RBQM strategy has the components it needs to meet regulatory expectations.

Established in 2019, Cyntegrity's MyRBQM® Academy units first-level online education, comprehensive instructor-led training, and practical case study workshops. Learn more at: www.academy.cyntegrity.com

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GUEST SPEAKER: 

Raik Knieknecht

KaDo Consulting

(Training & Change Manager)

Raik brings over 20 years of experience in the healthcare and pharmaceutical industries, focusing on Training, Change, and Knowledge Management.

At Novartis, he served as Global Head of Learning Innovation & Technology, leading efforts to modernize global training systems and drive transformative change in clinical operations. Earlier, as Regional Training Head for Europe, he standardized training frameworks across 25 teams, enhancing compliance and performance.

Raik has supported multiple Risk-Based Monitoring (RBM) implementations, ensuring operational excellence and regulatory compliance. Currently, he works as a freelance consultant, helping pharmaceutical organizations manage change and optimize performance through tailored training solutions.

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Keith Dorricott, MBB

Keith has been a qualified Lean Six Sigma Master Black Belt since 2007. He has a solid background in the practical use of process improvement, business process re-engineering, and metrics in clinical trials. Having a wealth of experience across processes in clinical trials and being a frequent speaker at conferences such as SCOPE and the MCC Summit, Keith helps make the complex understandable. In his spare time, he also facilitates and provides thought leadership for workgroups at the Avoca Quality Consortium, such as Centralized Monitoring, eCOA, and Vendor Oversight. 

June 26, 2024 Michal Helbin

A comprehensive approach to the management of risks in a clinical study. The platform is very well designed, it has been very well presented during the webinar. The platform is detailed but graphically appealing. It utilizes the smart risk categories as proposed by the TransCelerate Biopharma, uses some proprietary tools and knowledge as designed by the Cyntegrity and is easily scalable should any organization need to add more categories at any time. Its a product well done.

September 18, 2024 Hanlie Bester

I thoroughly enjoyed the 'mindsON RBQM Episode 27' webinar! Dr. Johann Proeve and Keith Dorricott provided valuable insights on selection of additional risk controls. The examples were well thought out, and I found the integration of LLM responses into the presentation particularly interesting. Looking forward to the next episode!

October 9, 2024 Charlene Dark Dark

The content and the speakers provided informative insights on the important topic of responsible AI implementation in clinical trials. The regulatory and compliance discussions were exceptionally helpful.

Appointments

  • February 19, 2025, 3:00 PM - 4:00 PM

Description

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).

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ABOUT "mindsON RBQM" WORKSHOPS

The mindsON RBQM workshops provide practical, system-agnostic guidance on the challenges of implementing and executing Risk-Based Quality Management (RBQM) in day-to-day clinical trial operations. These sessions emphasize interactive dialogue and problem-solving, offering a collaborative space to share experiences, explore strategies, and tackle real-world challenges.

Rooted in Quality by Design (QbD) principles, mindsON RBQM focuses on concepts and strategies without being tied to any specific system. For those looking to see these principles applied through technology, the actON QbD series offers complementary workshops with live demonstrations of use cases powered by the MyRBQM Portal.

Whether you choose to participate or simply observe actively, mindsON RBQM provides the knowledge and tools you need to navigate RBQM implementation confidently and effectively.

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