We’re excited to share the latest update highlighting the fantastic progress across our Working Groups. This quarter’s report showcases key achievements from our Projects and highlights the important and innovative work that’s still underway.

Explore the full report to see how each Project is making an impact. Don’t miss the detailed overview of the events and milestones that shaped this quarter’s journey.

pharmaverse Hackathon Series Featuring the {xportr} Package

Hackathon Kick-Off – 12 May 09:00–10:00 (EDT) / 14:00–15:00 (BST) / 15:00–16:00 (CEST)
Hackathon – 21 May 08:00–10:00 (EDT) / 13:00–15:00 (BST) / 14:00–16:00 (CEST)
Hackthon Wrap Up – 28 May 09:00–10:00 (EDT) / 14:00–15:00 (BST) / 15:00–16:00 (CEST)

Webinar: Biostatistical Considerations When Using RWD and RWE in Clinical Studies for Regulatory Purposes

21 May 11:00-12:00 (EDT) / 16:00-16:00 (BST) / 17:00-18:00 (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.

Registration will open 17 June.

Join us for the return of the Real World Evidence Working Group’s multi‑day virtual event on 30 September–1 October 2026. The event will run from 09:00–11:30 (EDT), 14:00–16:30 (BST), and 15:00–17:30 (CEST).

Registration will open 17 June.

The Conformance with the tumor.xpt Specification within the Nonclinical Topics Working Group has produced a White Paper ‘Conformance with the Technical Specifications Document for Submitting Nonclinical Datasets for Evaluation of Rodent Carcinogenicity Studies of Pharmaceuticals’ along with a set of Conformance Rules. This White Paper outlines the development of standardised conformance rules for tumor.xpt datasets to enable automated validation, improve data consistency, and reduce manual effort in regulatory submissions for carcinogenicity studies..

Please provide your comments by emailing workinggroups@phuse.global. Closing date for comments: 20 May 2026.

If you would like to get involved in a PHUSE Working Group Project, please explore the projects via the Volunteer Board and contact the PHUSE Office on workinggroups@phuse.global to express your interest. 

Working Group Report: Includes project updates, recent and upcoming deliverables and future plans for each Working Group.

Monthly Mailings: The monthly newsletter. Here you will find a full update from each month of the year, easily accessible and divided into key areas of PHUSE.

PHUSE Blogs: Fancy a quick read? A blog is a perfect way to catch up on all things Working Groups. Get the lowdown on the latest events from across the globe and stay updated on industry topics brought to you by industry professionals. 

Initiate and lead a new project under the PHUSE Working Groups umbrella. The new project must address problems of significant relevance to computational science related to drug, biological and device development and must meet all of the guidelines for projects within the collaboration, including the following mandatory requirements: 

• The projects must address significant research issues relevant to Computational Science

• The project must not attempt to address FDA policy issues

• There must be at least one Project Lead personally involved in planning and carrying out the project

New projects can be submitted anytime during the year, click here to submit.