actON QbD | Episode 4: How to reduce the high risks

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May 13, 2025, 2:00 PM - 3:00 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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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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Julien Goncalves

Julien, a scientist with 6 years of experience in pre-clinical and clinical research, leverages his solid scientific foundation in distinct roles within marketing and business development in the healthcare and life science industries. Effectively communicating scientific content for impactful results, Julien successfully overcomes the common misalignments between sales and marketing teams. As Cyntegrity’s RBQM Solutions Architect, he adeptly translates client needs into actionable RBQM solutions tailored to each organization. With his combination of scientific training and marketing acumen, he significantly contributes to Risk-based Quality Management within Clinical Trials.

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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.

Appointments

  • May 13, 2025, 2:00 PM - 3:00 PM

Description

To reduce the high risks, you must focus on reducing likelihood, impact, and/or improving detectability. Where should you focus first? And will your actions reduce the risk enough? Join us as we explore these questions and use Cyntegrity's myRBQM Portal to help control risks.

About "actON QbD" Workshops

Building on the success of our mindsON RBQM workshops, we're excited to introduce the actON QbD series. These workshops combine Quality by Design (QbD) principles with practical, technology-driven demonstrations using the MyRBQM Portal.

Each session highlights a specific use case, such as Protocol Design, Central Monitoring, Medical Monitoring, or many others. A subject matter expert will introduce the selected use case, followed by a live demonstration showcasing how the MyRBQM Portal supports and enhances the process.

Unlike the system-agnostic mindsON RBQM series, actON QbD offers a unique opportunity to explore AI-augmented workflows in action. The workshops demonstrate applying Cyntegrity's technology across various scenarios to deliver efficiency, precision, and actionable insights.

Join us to discover how Quality by Design can be brought to life across countless use cases, transforming workflows with actionable, technology-driven insights.

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