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The Working Groups Q2 Reports have now been published. Take a look at what our Working Groups have been working on this quarter, along with the events that have taken place.

The Optimizing the Use of Data Standards Working Group is seeking a Co-Lead to oversee maintenance of the ADRG (Analysis Data Reviewer's Guide) package under the Management of ODS Regulatory Referenced Deliverables (MRRD) project. Co-Leads will work under guidance of the MRRD Project Lead and are asked to serve two years in the role.  Responsibilities include:

• Reviewing updates to regulatory documents where PHUSE deliverables are referenced to ensure they are aligned

• Identifying any updates that are required due to updated regulatory documents or PHUSE member feedback

• Discussing the updates with the MRRD project team for agreement and cross-document alignment

• Overseeing the updates and publishing of deliverables.

For more information, go to Management of ODS Regulatory Referenced Deliverables or contact workinggroups@phuse.global.

To apply, please send a brief summary of interest and your qualifications to workinggroups@phuse.global by 7 August.

Hackathon: pharmaverse Hackathon series featuring the {aNCA} package

16 & 23 July 9:00-10:00 (EDT) / 14:00-15:00 (BST) / 15:00-16:00 (CEST)

The Data Transparency Working Group is preparing for its upcoming multi‑day virtual event, taking place 15–17 September 2026 at 10:00–12:30 (EDT) / 15:00–17:30 (BST) / 16:00–18:30 (CEST).

The event will focus on the evolving landscape of clinical data transparency, including approaches to data sharing, anonymisation, governance and enabling responsible access to clinical data.

The Real World Evidence Working Group is preparing for its upcoming multi‑day virtual event, taking place 30 September–1 October 2026 at 09:00–11:30 (EDT), 14:00–16:30 (BST), and 15:00–17:30 (CEST).

Join the PHUSE Community to explore the evolving landscape of real-world data (RWD), including its growing role in clinical research and regulatory decision-making. This event will bring together global experts to share insights, practical approaches, and real-world applications of RWD.

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, covering quality‑by‑design principles, risk assessment using critical‑to‑quality factors, targeted monitoring strategies, and approaches to overcome adoption challenges, while ensuring participant safety and regulatory compliance.