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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 its focus to RBQM and is 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 an exciting new project – OpenRBQM: Pre-Competitive Collaboration on Open-Source Software for RBQM – in collaboration with the Data Visualisation & Open Source Technology 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. See slide 104 for Michael’s presentation: Translating QbD Outcomes to Risk-Proportionate Oversight Including RBM: Successes and Challenges.

The Dataset-JSON as Alternative Transport Format for Regulatory Submissions project have continued to work within their sub-teams, producing a webinar where they presented their updates to the wider team. This hot topic project are working towards their CSS workshop, where they will be presenting the project findings and recommendations.

The Real World Evidence Working Group published their blog post on the Catalyst for Transformative Drug Discovery. This blog post delves into how real-world evidence is revolutionising drug discovery and offers insights that transcend the boundaries of controlled clinical trials. Watch this space! The Working Groups have got more blog posts planned for this year.

In addition to Working Group activities, the Community Forums have returned for 2024. Real World Evidence and Risk Based Quality Management have hosted a forum each in January and February, with more planned in April and throughout 2024.

Some of the Working Groups have expanded. We have four new projects that have started this Quarter, these projects are:

• Nonclinical – Supporting the Use of SEND for the Implementation of Virtual Control Groups
• Safety Analytics – Safety Analytics Education
• Data Visualisation & Open Source Technology – Demonstrating Real-World Impact of Modernization of Statistical Analytics (MSA) Framework 
• Risk Based Quality Management – OpenRBQM: Pre-Competitive Collaboration on Open-Source Software for RBQM