Working Groups – Q1 2024 Summary
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.

Working Groups – Q1 2024 Summary

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.

New Projects This Quarter
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

New Projects This Quarter

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

Published
It’s been a busy quarter across the eight Working Groups. There have been two published deliverables and there are many more in the works. The published deliverables are: Cloud Framework, Pre-Amble: white paper The Cloud Adoption in the Life Sciences Industry project produced its third deliverable. The white paper dives into adopting cloud-based solutions for GxP workloads. Understanding the essential characteristics of cloud services and solutions is important for determining the applicability of GxP requirements to specific cloud service providers and/or cloud-based solution models. Julia Initiative for High Performance Computing: white paper The project published their white paper this quarter. This paper provides an overview of Julia’s features and benefits for high-performance computing, including its fast compilation, dynamic typing, multiple dispatch, and built-in support for parallelism. It also discusses current real-world use cases of Julia and potential case studies for high-performance computing, along with recommended readings and references for further exploration.

Published

It’s been a busy quarter across the eight Working Groups. There have been two published deliverables and there are many more in the works. The published deliverables are:

Cloud Framework, Pre-Amble: white paper
- The Cloud Adoption in the Life Sciences Industry project produced its third deliverable. The white paper dives into adopting cloud-based solutions for GxP workloads. Understanding the essential characteristics of cloud services and solutions is important for determining the applicability of GxP requirements to specific cloud service providers and/or cloud-based solution models.
Julia Initiative for High Performance Computing: white paper
- The project published their white paper this quarter. This paper provides an overview of Julia’s features and benefits for high-performance computing, including its fast compilation, dynamic typing, multiple dispatch, and built-in support for parallelism. It also discusses current real-world use cases of Julia and potential case studies for high-performance computing, along with recommended readings and references for further exploration.

Under Review
There are currently three deliverables that are within the review stages. Watch this space! QTLS – Assessing the Use of Quality Tolerance Limits in the Pharmaceutical Industry Implementation of Estimands – Implementation of Estimands (ICH E9 (R1) in Data Standards (over 400 comments were received) Adverse Event Collection Recommendations

Under Review

There are currently three deliverables that are within the review stages. Watch this space!

QTLS – Assessing the Use of Quality Tolerance Limits in the Pharmaceutical Industry
Implementation of Estimands – Implementation of Estimands (ICH E9 (R1) in Data Standards (over 400 comments were received)
Adverse Event Collection Recommendations