mindsON RBQM | Episode 15: RBQM Implementation - Which existing roles need change, and what new ones are required?
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?
mindsON RBQM | Episode 16: RBQM should be standardized, shouldn't it?
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?
mindsON RBQM | Special Edition - At last: The ICH E6 (R3) draft has landed! What does it mean for RBQM?
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.
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About "mindsON RBQM" workshops: mindsON RBQM is a series of workshops 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 own experiences and participate in the interactive dialog. If you prefer to listen and observe, that's okay as well.
mindsON RBQM | Episode 17: Developing the Critical Skill of Data Analysis
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."
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About "mindsON RBQM" workshops: mindsON RBQM is a series of workshops 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 own experiences and participate in the interactive dialog. If you prefer to listen and observe, that's okay as well.
mindsON RBQM | Episode 18: What are the Top 10 Challenges with Risk Control?
In episode 14 of mindsON RBQM, 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.
mindsON RBQM | Episode 19: What about the unknown unknowns? How can we manage risks we don't even know about?
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.
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Welcome to mindsON RBQM, a tailor-made workshop series crafted to empower you in navigating the complexities of Risk-Based Quality Management (RBQM) implementation and daily execution. Each engaging session offers practical guidance, interactive discussions, and hands-on problem-solving exercises, allowing you to actively participate and share your unique experiences. Whether you prefer to dive into lively conversations or observe and absorb valuable insights, mindsON RBQM has something for everyone.
For a personalized learning experience, explore our diverse range of programs, instructor-led and on-demand courses available at the Cyntegrity Academy website: academy.cyntegrity.com
Join us today and elevate your RBQM expertise to new heights!
mindsON RBQM | Episode 20: How do RBQM and Decentralized Clinical Trials fit together?
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?
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Welcome to mindsON RBQM, a tailor-made workshop series crafted to empower you in navigating the complexities of Risk-Based Quality Management (RBQM) implementation and daily execution. Each engaging session offers practical guidance, interactive discussions, and hands-on problem-solving exercises, allowing you to actively participate and share your unique experiences. Whether you prefer to dive into lively conversations or observe and absorb valuable insights, mindsON RBQM has something for everyone.
For a personalized learning experience, explore our diverse range of programs, instructor-led and on-demand courses available at the Cyntegrity Academy website: academy.cyntegrity.com
Join us today and elevate your RBQM expertise to new heights!