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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…
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mindsON RBQM | Episode 15: The Risk Assessment is easy, right? Wrong! (Webinar | Online)
Language: English Time: 17.00 to 18.30 h (German time zone, CET) Price: 0 € (free of charge) Webinar: Describe and discuss the practical challenges with risk assessment. How many risks should you have? Should risks that are for multiple studies be included? Should you only include risks that are study specific? Should the impact score be based on the impact of the whole study or individual patients? 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…
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mindsON RBQM | Episode 14: QTLs – The Return! (Webinar | Online)
Language: English Time: 17.00 to 18.30 h (German time zone, CET) Price: 0 € (free of charge) Webinar: We ran a workshop on QTLs in 2022 and were inundated with questions. So we thought we needed to return to the subject! We will explore the latest thinking on QTLs, discuss why organizations find them so challenging to implement, suggest practical approaches, and have plenty of opportunity for lots more of your questions. 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 Global Risk Management | How Ukraine-based CRO adopts war as opportunity (Webinar | Online)
A War – A Low Probability Risk with High Impact In this special episode of mindsON Global Risk Management, our CEO, Artem Andrianov, Ph.D., speaks with Dr. Yuriy Lebed, the CEO of Pharmaxi LLC, a CRO based in Kyiv, Ukraine, that works with BioPharma and Medical Device companies across the globe. As a data science organization that is entirely focused on de-risking clinical trials and their conduct, tackling the unique set of risks that have low probability but have high, often global impact, is an objective that has been on our minds since the COVID-19 outbreak. What if we could predict and mitigate global threats such as pandemics, wars, and…