Working Groups Report – Q2 2026

It has been another busy quarter for the PHUSE Working Groups community, with continued activity across projects, events and volunteering opportunities. Highlights include the first pharmaverse Hackathon, featuring the {xportr} package. We are also pleased to share a newly published deliverable from the Risk Based Quality Management Working Group, new leadership opportunities in the Optimizing the Use of Data Standards Working Group, and three announcements for PHUSE Working Group events taking place later this year.

Optimizing the Use of Data Standards 

The Optimizing the Use of Data Standards Working Group is seeking a Co-Lead to oversee maintenance of the SDSP (Study Data Standardisation Plan) package under the Management of ODS Regulatory Referenced Deliverables (MRRD) project. Co-Leads will work under the guidance of the MRRD Project Lead and serve for two years.

Full details can be found here. To apply, please send a summary of your interest and qualifications to workinggroups@phuse.global by 14 July.

Nonclinical Topics

The SEND Industry Feedback Survey project, under the Nonclinical Topics Working Group, is looking for volunteers to support this exciting initiative.

This project will help gather valuable industry insights and feedback to support future discussions and improvements within the SEND space. If you are interested in contributing, collaborating with peers, and helping shape this project, we’d love to hear from you. Find out more information about the project on the Volunteer Board. To get involved, please complete the New Member Onboarding Form.

The Enhanced Risk-Based Quality Management (RBQM) Approaches for First-in-Human and/or Small Clinical Trials Project within the Risk Based Quality Management Working Group has published a new white paper.

This paper provides practical recommendations for applying risk-based quality management (RBQM) in small and early-phase clinical trials. It covers quality-by-design principles, risk assessment using critical-to-quality factors, targeted monitoring strategies, and approaches to overcoming adoption challenges while ensuring participant safety and regulatory compliance.