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, […]
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: 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 […]
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 […]
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 […]