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 […]
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
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
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
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
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
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
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
mindsON RBQM | Episode 17: RBQM should be standardized, shouldn’t it? (Webinar | Online)Read More »
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?
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
mindsON RBQM | Episode 15: The Risk Assessment is easy, right? Wrong! (Webinar | Online)Read More »