mindsON RBQM | Episode 33: The NEW mindsON RBQM Expert Working Group

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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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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. 

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Dr. Johann Proeve

Johann has over 40 years of experience as a biopharmaceutical industry expert, mainly in the former role of VP of Global Clinical Data Management at Bayer Healthcare. Besides being a much sought-after industry speaker, he brings data-driven realism to the table, ensuring that goals are implementable in the real world. Johann has a vast depth of experience in clinical research, which has been invaluable to many.

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.

Description

The NEW mindsON RBQM - Expert Working Group

Since their launch, our mindsON RBQM workshops have hosted over 30 sessions, engaging a dedicated community of professionals across the clinical trial landscape. By focusing on real-world challenges in implementing and advancing Risk-Based Quality Management (RBQM), these workshops have become a trusted space for collaboration and knowledge exchange.

We are excited to take this initiative to the next level by forming a dedicated Expert Working Group. This group will meet regularly to develop practical RBQM resources that address industry needs and keep pace with key developments, including the adoption of the ICH E6(R3) guidelines.

Why Now?

The recent adoption of the ICH E6(R3) guidelines signals a major shift in expectations around clinical trial design and execution, placing greater emphasis on proactive quality measures and efficient data oversight. With clearer definitions of roles, enhanced ethical safeguards, and an openness to innovative approaches like decentralized elements, the industry is entering an essential phase for risk-based practices.

Additionally, industry reports continue to highlight the effectiveness of centralized monitoring in improving patient safety and study oversight. Implementing streamlined, risk-focused processes helps sponsors and CROs transition smoothly while avoiding unnecessary complexity at the site level.

Since 2019, our workshops have connected us with thousands of professionals who have shared their insights, frustrations, and successes. This collective experience will inform the Expert Working Group’s direction as we shape actionable outputs that simplify processes and foster stronger stakeholder collaboration.

Your voice is welcome whether you’re a seasoned RBQM leader or simply passionate about making an impact. Join us at this session and help define the future of RBQM. 

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