Events

mindsON RBQM Workshop | Episode 35: Where does Quality by Design fit in?

ICH E8(R1) brought us Quality by Design (QbD). But where does it fit into the overall approach to RBQM? And what about Centralized Monitoring and Risk-Based Monitoring? Join our experts, Johann and Keith, as they provide their perspective on where QbD fits in. Come along to share your views via polling and whiteboards or just...

22 May

5:00 PM - 6:00 PM

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

Who needs to know about the risks identified in a clinical trial? And how is it best to communicate those risks and mitigations? What about new emerging risks that were unexpected? Join us as we explore these questions and use Cyntegrity’s myRBQM Portal to demonstrate how a system can aid communication.

03 Jun

4:00 PM - 5:00 PM

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mindsON RBQM Workshop | Special Edition: Audit trails exposed – Why they matter for RBQM

Plotting data from audit trails in data can reveal the behavior underlying the trial. Who provided the data and when? How often was it modified, if at all? The focus on the underlying process can lead to interesting indicators of risk and may capture emerging issues earlier than focusing only on the captured data itself....

12 Jun

5:00 PM - 6:00 PM

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mindsON RBQM Workshop | Special Edition: Responsible AI Outcomes: Validating Performance and Protecting Trial Data

AI Models in Clinical Trials: Addressing Business-Critical Questions AI already flags protocol risk, detects emerging safety signals, and trims patient-data review time – yet boards and regulators still press for answers: Does the model truly work? Is our trial data demonstrably secure? What hard ROI can we show? In this one-hour executive briefing, Microsoft and...

25 Jun

5:00 PM - 6:00 PM

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actON QbD Workshop | Episode 6: Centralized Monitoring is About Being Pro-Active!

Centralized Monitoring is an important way of monitoring risks in clinical trials. But how does it link to the risk assessment? What risks is it actually monitoring? Does every signal need to be investigated? And how do you go about it? Join us as we explore these questions and use Cyntegrity’s myRBQM Portal to show...

01 Jul

4:00 PM - 5:00 PM

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mindsON RBQM Workshop | Episode 36: Trial-Level Risks – Should you use a KRI, a QTL, or Acceptable Ranges?

Should KRIs ever be used at the trial level or only QTLs? ICH E6(R3) introduces Acceptable Ranges at the trial level – what are those? Join our experts, Johann and Keith, discussing trial-level risk monitoring. Come along to share your views via polling and whiteboards or just to listen and learn.

09 Jul

5:00 PM - 6:00 PM

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mindsON RBQM Workshop | Episode 37: Why is setting thresholds so tricky?

Have you come across KRI thresholds that are constant, or variable, or relative? How easy is it to use historic data to set them? Can they be changed during the trial? Are there any additional considerations for QTLs and Acceptable Ranges? Join our experts, Keith and Johann, as they discuss these questions. Come along to...

24 Sep

5:00 PM - 6:00 PM

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mindsON RBQM Workshop | Episode 38: How to design a Key Risk Indicator that works

When designing a Key Risk Indicator (KRI), many considerations must be made, such as where the data is coming from, how often it’s refreshed, whether the KRI is closely related to a risk, when to kick it off, and whether there will be too many false positives or negatives. Join our experts, Johann and Keith,...

22 Oct

5:00 PM - 6:00 PM

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mindsON RBQM Workshop | Episode 39: Revealed – Best practices for RBQM oversight

Oversight is an essential topic in ICH E6(R3), and the mindsON RBQM industry Expert Working Group has been focusing on best practices for RBQM oversight. Come along and find out what they’ve been up to and what the rich discussions have led to. Find out where you can get a free resource to help you...

12 Nov

5:00 PM - 6:00 PM

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mindsON RBQM Workshop | Episode 40: Christmas Contingencies

As the countdown to the holiday season intensifies, we look at festive examples of risks, existing controls, mitigations, contingencies, and a KRI. Join our experts, Keith and Johann, as they provide a seasonal perspective on QbD and RBQM. Come along to share your views via polling, whiteboards, or just to listen and learn. Bring your...

10 Dec

5:00 PM - 6:00 PM

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