An area of much debate (and confusion) is the differences, similarities, and overlaps between Risk-Based Quality Management, Quality by Design, Centralized Monitoring, Centralized Statistical Monitoring, Remote Monitoring, and Risk-Based Monitoring. Or, in the alphabet soup of our industry, RBQM, QbD, CM, CSM, RM and RBM. At this workshop, our industry experts will provide their perspectives and get the perspectives of […]
Categories: Webinar
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 […]
Categories: Webinar
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 […]
Categories: Webinar
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 […]
Categories: Webinar
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 […]
Categories: Webinar
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 […]
Categories: Webinar
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 […]
Categories: Webinar
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 […]
Categories: Webinar
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 […]
Categories: WebinarLanguage: 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? […]
Categories: Webinar