Working Groups Quarter 1 2024 Summary |
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Welcome to the PHUSE Quarter 1 2024 Working Group Report. New Year new focus, the Working Group formally known as Risk Based Monitoring has expanded their focus to RBQM, Now called Risk Based Quality Management. This Working Group will identify innovative approaches in the planning (Quality by Design, Critical to Quality, Risk Identification and Characterisation), conduct (Risk Control), and continuous improvement (Risk Review, Risk Communication) elements of RBQM that support proactive management data reliability and participant well-being. They have also launched a new exciting project “OpenRBQM: Pre-Competitive Collaboration on Open-Source Software for RBQM” in collaboration with the Data Visualisation and Open Source Technologies working group. Michael Walega on behalf of the RBQM leads presented at the Duke/FDA workshop ‘Building Quality into the Design and Conduct of Clinical Studies: Integrating Quality by Design (QbD) and Risk-Based Monitoring (RBM) Approaches’ Michael’s Presentation dove into the Translating QbD Outcomes to Risk-Proportionate Oversight Including RBM: Successes and Challenges(see slide 104). The Dataset-JSON as Alternative Transport Format for Regulatory Submissions project has continued to work within their sub teams, producing a webinar where they presented their updates to the wider team, this hot topic project is working towards their CSS workshop where they will be presenting the project findings and recommendations. The Real World Evidence Working Group published their blog on the Catalyst for Transformative Drug Discovery. This blog post delves into how real-world evidence is revolutionising drug discovery and offering insights that transcend the boundaries of controlled clinical trials. Watch this space! The Working Groups have got more blogs planned for this year. In addition to Working Group activities, the community forums have returned in 2024. With both the Real World Evidence and Risk Based Quality Management hosting a forum each in January and February with more planned in April and throughout 2024. |
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