Events

actON QbD | Episode 1: Critical to Quality Conundrum

Critical to Quality Factors (CTQs) are an essential part of Quality by Design (QbD), as we know from E8 (R1) and E6 (R3) (draft). But what is a CTQ, why is it important, and how would you use one anyway? Join us as we explore these questions and use Cyntegrity’s myRBQM Portal to show where...

11 Feb

4:00 PM - 5:00 PM

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mindsON RBQM | Episode 34: Change – Why 70% fail and how to succeed in Risk Management

The draft ICH E6 (R3) guidelines strongly emphasize Risk Management across clinical trials – from monitoring to quality oversight and data integrity. Whilst industry data shows 90% adoption of risk assessments, there is only 50% adoption of KRIs and 25% adoption of QTLs (required since 2016). While the need for change is clear, successfully implementing these changes remains...

19 Feb

4:00 PM - 5:00 PM

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actON QbD | Episode 2: Thinking critically to identify risks

Identifying risks that matter is fundamental to a risk-based approach to clinical trials. What are some best practices, and what do you do with the risks once you’ve identified them? Join us as we explore these questions and use Cyntegrity’s myRBQM Portal to show how risks can be handled.

11 Mar

4:00 PM - 5:00 PM

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actON QbD | Episode 3: Not all risks are born equal

Some risks are greater than others. But how do you determine the highest risks for the clinical trial? Is it important to know the trial processes, or is that a distraction? Why does the detectability of a risk matter? Join us as we explore these questions and use Cyntegrity’s myRBQM Portal to show risk evaluation.

08 Apr

4:00 PM - 5:00 PM

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

To reduce the high risks, you need to 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 system to help control risks.

13 May

4:00 PM - 5:00 PM

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mindsON RBQM | 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...

22 May

5:00 AM - 6:00 PM

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actON QbD | 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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actON QbD | 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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