Content Comparison

The Working Groups quarterly report is now live! These reports highlight the fantastic progress across our projects, featuring key achievements and the exciting work still underway. Explore the complete reports to see how each project is driving innovation and impact.

Revisit the events from this quarter and explore what’s coming up next.

Community Forum: The Causal Roadmap,Targeted Learning and TMLE: What Is That All About?

29 January 2026 at 10:00-11:00 (EST) / 15:00-

16:

00 (

GMT) / 16:00-

17:00 (CET)

Information and Registration

The Data Transparency Working Group welcomes a new lead Abby McDonell!

Abby previously co-led the PHUSE Good Transparency Practice Working Group project, where she helped define best practices for data transparency and created guidance to ensure anonymised data complies with legal requirements while preserving data utility.

Abby is a Senior Program Manager for the Clinical Trial Transparency team at Privacy Analytics. Abby leads teams that leverage advanced AI-enabled technology to deliver anonymisation services for top 10 pharma customers.

The Rare Disease/Small Population Data Sharing project within the Data Transparency Working Group has published a new White Paper. The purpose of this White Paper is to review potential barriers to the sharing of rare disease data such as risk of re-identification and invasion of privacy (balanced against maintaining data utility) to understand if and how these barriers apply to controlled access data sharing under specific contextual assumptions.

The RWD Guideline for Programming and Analysis Processes project within the Real World Evidence Working Group has produced a White Paper, ‘RWD Guideline for Programming and Analysis Processes’ which is calling for feedback.

As per FDA1.1, Real-World Data (RWD) are data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources. Examples include data derived from Electronic Health Records (EHRs), Claims and/or billing data, Product and/or disease registry data, other data sources that can inform on health status (e.g., data collected from wearables, patient generated data).

Please provide your comments by emailing workinggroups@phuse.global. Closing date for comments: 5 September.

The Risk Based Quality Management Working Group have produced a survey on the topic of SDR/SDV in China.

The goal of this survey is to gain insight into how companies across the industry are implementing SDR and SDV in sites in China. The output of the survey will be used to develop a reference document for informing future study approaches and/or adjusting current approaches to better align with global standards.

The closing date for completing the survey: 20 September.

The Nonclinical Topics Working Group is excited to announce a multi-day virtual event coming 10–12 February 2026 at 09:00–11:30 (EST) / 14:00–16:30 (GMT) / 15:00–17:30 (CET)

We have an exciting agenda of expert presentations, interactive breakout sessions and project updates, spread across three days. The event will focus on four core themes – new approach methodologies (NAMs), nonclinical predictive modelling, machine learning and PHUSE project contributions and developments – and enable attendees to explore each topic in depth with leaders from industry, regulatory agencies and the wider PHUSE Community.

Full agenda and registration details coming soon!

We’re looking forward to welcoming you back as the Data Transparency Working Group returns with another multi-day virtual event, taking place 15–17 September 2026.

Stay tuned for more details and registration information coming soon!

We’re pleased to announce that the Real World Evidence Working Group will be holding its second multi-day virtual event from 30 September–1 October 2026.

Stay tuned for more details and registration information coming soon!

The QC Workflow Optimisation project within the Emerging Trends & Innovation Working Group have published a survey exploring the current state of Quality Control across the industry.

This survey aims to capture an industry-wide view of current Quality Control practices, how they may need to evolve, and the potential role of emerging technologies such as AI. Your input will help shape future PHUSE discussions, highlight areas for improvement or standardisation, and guide next steps for the QC Workflow Optimisation project.

The survey will remain open from 3 December – 13 January. All responses will be collected anonymously.

The Value of Plain Language Summaries of Trial Results (PLSs) project team within the Data Transparency Working Group, is calling for volunteers!

This project has been initiated because whilst the industry has put significant efforts into developing and disseminating plain language summaries of trial results (PLSs) to promote transparency and engagement, there remains a gap in quantitative evidence of how these documents are used and what value they bring to the trial participants and the general public. Gathering feedback from trial participants – the primary audience for PLSs – and other readers will provide meaningful insights into their value and inform improvements.

The team will be creating a survey to evaluate the value of PLSs and the survey feedback will be shared as a white paper authored by the group.

If you’d like to become a valued project member, please get in touch with workinggroups@phuse.global by 19 January 2026 ahead of the kick off meeting scheduled for Tuesday 20 January 08:00 EST / 13:00 GMT / 14:00 CET.

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.