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PHUSE collaborations are organised into a number of specialist Working Groups, each with a broad topic area. The Working Groups have specific projects designed to achieve a set of particular objectives. This page will highlight the latest news and information from our projects. Participation is open to anyone who wants to contribute and if you would like to get involved, please email workinggroups@phuse.global.

Data Transparency Autumn Event 2025 – Call for Speakers is Open!

Data Transparency Autumn Event 2025 – Call for Speakers is Open!

Call for Speakers is officially open for the Data Transparency Autumn Event 2025!

This is a fantastic opportunity for those passionate about data transparency to share their bold ideas, fresh perspectives and real-world experience.

The event will take place virtually 16–18 September, meaning you can participate from anywhere in the world! Plus, there’s no need to block out the whole day, as sessions are delivered in short bite-sized chunks from 10:00-12:30 (EDT) / 15:00-17:30 (BST) / 16:00-18:30 (CEST)

Submit your 150-word abstract by 12 June for the chance to take part in one of the most focused, forward-looking events in the transparency space.

Submit Abstract

AI/ML in Digital Health Technologies (DHTs) Community Forum

AI/ML in Digital Health Technologies (DHTs) Community Forum

AI and SaMD in Healthcare: From Compliance to Patient-Centred Innovation

This Community Forum will be held virtually on 18 June at 11:00 (EDT) / 16:00 (BST) / 17:00 (CEST)

Information and Registration

End-to-End RBQM Webinar

Value-Driven Clinical Data Review, Together

This webinar will be held virtually on 26 June at 10:00 (EDT) / 15:00 (BST) / 16:00 (CEST)

Information and Registration

Real World Evidence Community Forum

OMOP – A Common Data Model Enabling the Analysis of RWD

This Community Forum will be held virtually on 19 July at 9:00 (EDT) / 14:00 (BST) / 15:00 (CEST)

Information and Registration

The Implementation of Estimands (ICH E9 (R1)) using Data Standards project within the Optimizing the Use of Data Standards Working Group, have published a new White Paper and Example Document!

This white paper provides recommendations and examples to illustrate the implementation of the estimands framework introduced by the ICH E9(R1) Addendum on Estimands and Sensitivity Analysis in Clinical Trials to the Guideline on Statistical Principles for Clinical Trials [ICH E9(R1), 2019] using data standards (as part of the clinical data flow).

The Implementation of Estimands (ICH E9 (R1)) using Data Standards project within the Optimizing the Use of Data Standards Working Group, have published a new White Paper and Example Document!

This white paper provides recommendations and examples to illustrate the implementation of the estimands framework introduced by the ICH E9(R1) Addendum on Estimands and Sensitivity Analysis in Clinical Trials to the Guideline on Statistical Principles for Clinical Trials [ICH E9(R1), 2019] using data standards (as part of the clinical data flow).

The Dataset-JSON as Alternative Transport Format for Regulatory Submissions project within the Optimizing the Use of Data Standards Working Group, has published its Business Case.

Dataset-JSON is a widely accepted data format that will streamline data exchange between organisations. Moving to Dataset-JSON will prepare us for the current digital world and enable companies to more accurately, completely and efficiently represent their clinical research data, to better serve their patients/customers. Dataset-JSON supports current data standards but also allows for standards to evolve and removes current limitations imposed by xpt format.

The Dataset-JSON as Alternative Transport Format for Regulatory Submissions project within the Optimizing the Use of Data Standards Working Group, has published its Business Case.

Dataset-JSON is a widely accepted data format that will streamline data exchange between organisations. Moving to Dataset-JSON will prepare us for the current digital world and enable companies to more accurately, completely and efficiently represent their clinical research data, to better serve their patients/customers. Dataset-JSON supports current data standards but also allows for standards to evolve and removes current limitations imposed by xpt format.

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.