Voices from the industry

Learn how RBQM is applied in practice
across the industry

Hear from sponsors, CROs, and industry experts on applying RBQM, managing risk, and supporting clinical trial oversight.

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July
07
2026
2026-07-07 17:00:00
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mindsON RBQM | E47: QbD under ICH E6(R3) – How CTQs Underpin Risk-Proportionate Oversight

5:00 PM – 6:00 PM
This session explores how QbD fits within RBQM under ICH E6(R3), with a focus on translating Critical to Quality factors into practical oversight decisions. We will discuss how CTQs shape study design, risk assessment, and proportionate monitoring — and why focusing on what matters most is essential for patient safety, data reliability, and inspection readiness.
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  • 60-minute live session
  • Includes Q&A
  • Interactive

Upcoming Webinars

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4:00 PM – 5:00 PM
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09
July
2026

actON QbD | E17: How to Translate CTQs into Practical Study-Level Risks

A practical follow-up session on translating Critical to Quality factors into study-level risks, controls, KRIs/QTLs, and monitoring priorities. The focus is on turning QbD thinking into operational RBQM decisions.
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5:00 PM – 6:00 PM
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24
Sept
2026

mindsON RBQM | E48: Measuring Risk in RBQM: KRIs, QTLs, ARs, and KPIs – Where Teams Get It Wrong

This session looks at how teams use – and sometimes misuse – KRIs, QTLs, Acceptable Ranges, and KPIs in RBQM. We will discuss how to avoid metric overload, define thresholds with purpose, and ensure that risk measures support meaningful oversight decisions rather than passive reporting.
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4:00 PM – 5:00 PM
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29
Sept
2026

actON QbD | E18: Build a Better Risk Metric: From Signal to Decision

An applied session on designing risk metrics that support decisions. We will connect signals, thresholds, review expectations, and follow-up actions so metrics become useful for oversight — not just reporting.
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5:00 PM – 6:00 PM
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20
Oct
2026

mindsON RBQM | E49: Avoiding Unnecessary CAPA: How Risk-Proportionate Thinking Reduces Fire-Fighting

This session explores how RBQM can help teams prevent issues before they escalate by linking risk management and issue management. The focus is on using prioritized risks, planned controls, and earlier detection to reduce fire-fighting, avoid unnecessary CAPA, and support more proactive oversight.
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4:00 PM – 5:00 PM
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22
Oct
2026

actON QbD | E19: Seeing it Coming: Preemptive Risk Detection and Proportionate Action

A practical scenario-based session on detecting risk signals early and acting proportionately before they become issues or escalate unnecessarily. The focus is on connecting risk management and issue management in practice, with clear decision rationale and traceable oversight.
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5:00 PM – 6:00 PM
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12
Nov
2026

mindsON RBQM | E50: Detecting Issues in RBQM: Using What Goes Wrong to Drive Continuous Improvement

This session explores how different issue types in RBQM can be detected and used as learning signals to reduce risk and improve oversight. The focus is not only on managing issues, but on using what goes wrong to improve risk mitigations, monitoring focus, and continuous oversight.
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4:00 PM – 5:00 PM
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16
Nov
2026

actON QbD | E20: How to Feed Issues Back into Risk Assessment and Monitoring Strategy

This session explores how different issue types in RBQM can be detected and used as learning signals to reduce risk and improve oversight. The focus is not only on managing issues, but on using what goes wrong to improve risk mitigations, monitoring focus, and continuous oversight.
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5:00 PM – 6:00 PM
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02
Dec
2026

mindsON RBQM | E51: If Santa Embraced QbD, RBQM, and AI: A Light-Hearted Look at Better Trial Oversight

A light-hearted end-of-year session using Santa’s present production and delivery as a playful scenario for QbD, RBQM, and AI oversight. We will explore risk identification, prioritization, mitigation, and human-in-the-loop decision-making in a practical but festive way.
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4:00 PM – 5:00 PM
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03
Dec
2026

actON QbD | E21: AI in MyRBQM: What Works, What Needs Review, and What Comes Next

A practical end-of-year demo of selected AI-assisted capabilities in the MyRBQM Portal, using a light seasonal scenario. We will explore what AI can support today, where human review remains essential, and how responsible AI can help strengthen QbD/RBQM oversight.
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AI Use in Clinical Trials Is Increasing.
So Are Regulatory Expectations.

Regulators expect controlled, documented, and reviewable AI use. Prepare your teams to apply AI within GCP and computerized system requirements.