actON QbD | Episode 5: Who to Tell About the Risks?

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Moderators

Moderator 1 of the webinar: MyRBQM Academy<br>by Cyntegrity

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

Moderator 2 of the webinar: Dr. Johann Proeve<br><i>Chief Scientific Officer<br>(Cyntegrity)</i>

Dr. Johann Proeve
Chief Scientific Officer
(Cyntegrity)

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.

Moderator 3 of the webinar: Keith Dorricott, MBB<br><i>Lead Instructor<br>(MyRBQM Academy)</i>

Keith Dorricott, MBB
Lead Instructor
(MyRBQM Academy)

A Master Black Belt since 2007, Keith applies Lean Six Sigma to optimize clinical-trial workflows, reengineer processes, and drive performance metrics. A frequent speaker at SCOPE and the MCC Summit, he makes complex methodologies practical. He leads the mindsON RBQM Expert Working Group and facilitates Avoca Quality Consortium workstreams on Centralized Monitoring, eCOA, and Vendor Oversight.

Moderator 4 of the webinar: <p>Julien Goncalves<br><i>BD | Head of Growth<br>(Cyntegrity)</i></p>

Julien Goncalves
BD | Head of Growth
(Cyntegrity)

Julien brings years of pre-clinical and clinical research expertise to his strategic leadership role. A dynamic speaker and masterful demonstrator, he thrives in customer-facing engagements, translating complex scientific insights into hands-on RBQM solutions. By bridging sales and marketing through clear, consultative communication, Julien accelerates adoption, deepens client relationships, and delivers measurable impact across the healthcare and life sciences sectors.

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.

October 22, 2025 Naomi Bossman

I appreciate the expertise and interpersonal dynamic of the presenters/moderator, as well as, examples, lessons learned, exercises, and ability to learn from other's experiences. Big fan of Cyntegrity! Thank you for hosting these webinars.

November 12, 2025 Mary Banach

Thank you - This webinar was exactly what is needed in the CDM Community. Mary Banach Chair DIA CDM Community

Why Attend?

Risks range from mild protocol hiccups to “danger of death,” but the biggest failure is a silent risk. In actON QbD | Episode 5: “Who to Tell About the Risks?” we zoom in on the human side of Quality by Design:

 • Who must hear the signal first? Study team, medical monitor, vendor, executive sponsor?

 • When is the right moment to flag it? At detection, trend confirmation, or action trigger?

 • How can a simple workflow or RACI chart keep everyone accountable, without drowning inboxes?

Join Keith and Julien for a fast-moving, 45-minute discussion packed with:

 >> Live polls and chat debates on real-world “danger-of-death” scenarios

 >> A walk-through of Keith’s latest visual workflow for risk communication

 >> Practical templates you can copy straight into your next RBQM plan

Bring your keyboard: we’ll crowd-source best practices on-the-spot. Listen in, vote, or jump on the mic—the floor is yours!

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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