Hot Topics

Hot Topics

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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.

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.

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Real World Evidence

Real World Evidence

The RWD Guideline for Programming and Analysis Processes Project within the Real World Evidence Working Group has published a new White Paper. This paper offers practical guidance for statistical programmers on applying real‑world data (RWD) to produce regulatory‑grade real‑world evidence (RWE), covering study design, data fitness, governance, ethics, vendor engagement, bias management, and regulatory submission considerations.

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Real World Evidence

Real World Evidence

Community Forum: Capturing the Patients Voice Through Lived Experience Across Diaries and Social Media

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

Data Transparency Autumn Event – Call For Speakers

Data Transparency Autumn Event – Call For Speakers

The Data Transparency Working Group invites abstract submissions 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.

Focus your submission on these central themes and submit an abstract by 8 May to contribute to the discussion.

Click here for more information.

Real World Data Autumn Event – Call For Speakers

Real World Data Autumn Event – Call For Speakers

We’re excited to announce Call for Speakers for the Real World Evidence Working Group’s second multi‑day virtual event is now open! Taking place 30 September – 1 October 2026, from 09:00–11:30 (EDT) / 14:00–16:30 (BST) / 15:00–17:30 (CEST).

Submit your abstract by 8 May for the chance to present.

Focus your submission on these central themes:

  • Optimising the Generation of Real‑World Evidence with NLP & AI

  • Digital Endpoints Generated from Real‑World Data

  • Data Sources, Lineage and Provenance

  • Vendor–Sponsor Governance and Alignment

  • Any Other Theme that Tackles the Challenges in Using Real‑World Data

Click here for more information.

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Emerging Trends & Innovation – Calling For Feedback

Emerging Trends & Innovation – Calling For Feedback

The Integration of Omics Data into Clinical Drug Development project within the Emerging Trends & Innovation Working Group has published a new white paper, Framework for Integrating Omics Data with Other Clinical and Non-Clinical Data Sources which is now open for public review.

This white paper proposes a framework for integrating multi-omics data with clinical and non-clinical datasets, combining BioCompute for workflow documentation and MultiAssayExperiment (MAE) for data management. It aims to improve standardisation, interoperability, and reproducibility to better support personalised medicine and regulatory use. 

The team welcome feedback on the paper by 31 March . Please send responses to workinggroups@phuse.global.

Real World Evidence – Calling For Feedback

Real World Evidence – Calling For Feedback

The Quality and Reusability of Real World Data Project within the Real World Evidence Working Group has produced a White Paper ‘Real-World Data Reliability and Integrity: Ensuring Real-World Data is Fit for Use for Regulatory Submissions’. This White Paper focuses on the usability of real-world data sources for regulatory submission purposes. To assess the fit for use of this data, we need to assess the relevance and the reliability of the data.

Please provide your comments by emailing workinggroups@phuse.global. Closing date for comments: 24 April 2026.

PharmaForest: A Collaborative Repository of SAS Packages for Pharmaceutical Industry project team within the Data Visualisation & Open Source Technology Working Group, is calling for volunteers!

PharmaForest is a collaborative initiative focused on improving how SAS programming is developed and shared across the pharmaceutical industry. Built on the SAS Packages Framework (SPF), it promotes reusable, standardised SAS packages to reduce duplication, improve efficiency, and support compliance.

By combining an open package repository with community collaboration and practical guidance, PharmaForest helps move SAS programming from siloed approaches to a more scalable, industry-wide model.

If you’d like to become a valued project member, please get in touch with workinggroups@phuse.global.

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.