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mindsON RBQM Workshop | Episode 24: Will AI really unlock the power of RBQM? (Webinar | Online)
As generated by ChatGPT: „Are you ready to revolutionize your Risk-Based Quality Management (RBQM) practices? Don’t miss our upcoming webinar, where we will explore the incredible potential of Artificial Intelligence (AI) in RBQM and how it can drive efficiency and ensure patient safety. During this dynamic session, our industry experts will explore the applications, benefits, and best practices of integrating AI into RBQM processes.“ ABOUT „mindsON RBQM“ WORKSHOPS mindsON RBQM is a series of workshops by Cyntegrity’s MyRBQM Academy that provides practical advice on the challenging aspects of an RBQM roll-out and its daily execution. Each workshop allows room for interactive dialogue and problem-solving exercises. We invite you to share…
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mindsON RBQM Workshop | Episode 23: What is a Critical to Quality Factor anyway? (Webinar | Online)
The guideline for Good Clinical Practices, ICH E6 (R3) draft, and ICH E8 (R1) introduce Critical to Quality (CTQ) Factors. What are they? How should they be used as part of RBQM? And whatever happened to critical processes and critical data? ABOUT „mindsON RBQM“ WORKSHOPS mindsON RBQM is a series of workshops by Cyntegrity’s MyRBQM Academy that provides practical advice on the challenging aspects of an RBQM roll-out and its daily execution. Each workshop allows room for interactive dialogue and problem-solving exercises. We invite you to share your experiences and participate in the interactive dialog with our well-known industry experts, Johann Proeve (PhD) and Keith Dorricott (MBB). If you prefer…
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mindsON RBQM | Episode 20: How do RBQM and Decentralized Clinical Trials fit together? (Webinar | Online)
Language: English Time: 17.00 h (German time zone, CET) / 11 am ET (90 min.) Price: 0 € (free of charge) Webinar:Decentralized Clinical Trials offer opportunities to improve recruitment rates and participant engagement and increase the diversity of those in the trial. How do they fit into the framework of RBQM? Are there new risks we need to be aware of? What is a „mindsON RBQM workshop“?mindsON RBQM is a series of workshops that provides practical advice on the challenging aspects of an RBQM roll-out and its daily execution, performed by Cyntegrity Germany GmbH – the holistic RBQM solution provider. Each workshop allows room for interactive dialogue and problem-solving exercises.…
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mindsON RBQM | Episode 19: What about the unknown unknowns? How can we manage risks … (Webinar | Online)
Language: English Time: 17.00 h (German time zone, CET) / 11 am ET (90 min.) Price: 0 € (free of charge) Webinar:Donald Rumsfeld famously talked about the challenge of the „unknown unknowns.“ When you carry out your risk assessment, how can you add those risks you don’t even know about? This is where experience from vast numbers of clinical trials can be useful – standard KRIs and statistical data monitoring. What is a „mindsON RBQM workshop“?mindsON RBQM is a series of workshops that provides practical advice on the challenging aspects of an RBQM roll-out and its daily execution, performed by Cyntegrity Germany GmbH – the holistic RBQM solution provider. Each…
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mindsON RBQM | Episode 18: What are the Top 10 Challenges with Risk Control? (Webinar | Online)
Language: English Time: 17.00 h (German time zone, CET) / 11 am ET (90 min.) Price: 0 € (free of charge) Webinar:In Episode 14 of the mindsON RBQM Workshop, we focused on the everyday challenges of completing a risk assessment. But once you’ve got your prioritized risks, how do you go about mitigating/controlling them? We’ll describe the top challenges we’ve encountered when teams go through this exercise and suggest ways to overcome them. What is a „mindsON RBQM workshop“?mindsON RBQM is a series of workshops that provides practical advice on the challenging aspects of an RBQM roll-out and its daily execution, performed by Cyntegrity Germany GmbH – the holistic RBQM…
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mindsON RBQM | Episode 17: Developing The Critical Skill Of Data Analysis (Webinar | Online)
Language: English Time: 17.00 h (German time zone, CEST) / 11 am EDT (90 min.) Price: 0 € (free of charge) Webinar:What are the skills we need people to have when analyzing KRIs and other risk indicators? How can we help people develop those skills? We will deep-dive into an example of KRI analysis to show how the D-I-G-R root cause analysis method is more effective than the overly simplified „Five Whys.“ What is a „mindsON RBQM workshop“?mindsON RBQM is a series of workshops that provides practical advice on the challenging aspects of an RBQM roll-out and its daily execution, performed by Cyntegrity Germany GmbH – the holistic RBQM solution…
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mindsON RBQM | Special Edition – The ICH E6 (R3) draft has landed! What does it mean for RBQM? (Webinar | Online)
Language: English Time: 17.00 to 18.00 h (German time zone, CEST) / 11 am EDT Price: 0 € (free of charge) Webinar:The industry has been waiting with bated breath for the update to E6. And now we have the draft E6 (R3) open to public consultation. So what are the implications for RBQM? Can we forget about QTLs? Is on-site monitoring and 100% SDV the gold standard? Join our RBQM experts, Johann and Keith, as they give their perspective on the new draft of GCP and how it might impact RBQM in a Special Edition of the popular mindsON RBQM series. What is a „mindsON RBQM workshop“?mindsON RBQM is a…
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mindsON Central Monitoring | Episode 4 – Optimizing Clinical Trials: Synergizing Onsite & Centralize (Webinar | Online)
Language: English Time: 16.00 to 17.30 h (German time zone, CEST) Price: 0 € (free of charge) Webinar:In response to the growing interest in combining onsite and centralized monitoring approaches, we are excited to have Dr. Yuriy Lebed, CEO of Pharmaxi LLC, a Ukraine-based CRO, along with our CEO, Artem Andrianov, Ph.D., to discuss the latest thinking, examine the challenges organizations encounter in integrating these monitoring methods, and provide practical solutions to overcome these obstacles. In this 90-minute interactive workshop, you’ll have the opportunity to engage with key topics surrounding onsite and centralized monitoring, such as: • Latest trends and insights on combining onsite and centralized monitoring in clinical trials…
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mindsON RBQM | Episode 17: RBQM should be standardized, shouldn’t it? (Webinar | Online)
Language: English Time: 17.00 to 18.30 h (German time zone, CET) Price: 0 € (free of charge) Webinar: How much of RBQM can be standardized, and how much flexibility is still necessary? Some companies seem to always start from scratch, while others try to standardize as much as possible. What is right and what is wrong with the two approaches? And how can you get the balance right? What is a „mindsON RBQM workshop“? mindsON RBQM is a series of workshops that provides practical advice on the challenging aspects of an RBQM roll-out and its daily execution, performed by Cyntegrity Germany GmbH – the holistic RBQM solution provider. Each workshop…
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mindsON RBQM | Episode 16: RBQM implementation – Which existing roles need change, and what new ones (Webinar | Online)
Language: English Time: 17.00 to 18.30 h (German time zone, CET) Price: 0 € (free of charge) Webinar: Since Risk-Based Monitoring was introduced in 2013 by FDA and EMA, organizations have taken many different approaches to implementation. What activities typically need to be performed for RBQM to work well? Which roles usually perform these activities? What new roles are typical, and what has happened to existing roles? What is a „mindsON RBQM workshop“? mindsON RBQM is a series of workshops that provides practical advice on the challenging aspects of an RBQM roll-out and its daily execution, performed by Cyntegrity Germany GmbH – the holistic RBQM solution provider. Each workshop allows…
