Content Comparison

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)

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.

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.

In its 14th year, the /wiki/spaces/WEL/pages/38993921 will be in Utrecht, the Netherlands 20-21 May.

At the heart of the event is the PHUSE Working Groups’ mission to tackle unmet computational science needs in support of health product development and regulatory review, ultimately bringing safe and effective medical products to those who need them.

The CSS agenda will feature a variety of activities, including expert-led plenary sessions, interactive workshops and dedicated Working Group Breakout Sessions that drive forward existing initiatives and explore new ones. Attendees will also have the chance to attend the Poster Session, providing the opportunity to share knowledge and engage in discussions on various computational science topics.

PHUSE is excited to welcome attendees from across pharma, CROs, academia, health authorities, technology vendors and SDOs to come together for this collaborative and forward-thinking experience. 

Please visit the PHUSE website for more information.

Webinar 2: Estimands in Real-World Evidence Studies

This webinar will explore the pivotal role of estimands in real-world evidence (RWE) studies, bridging the gap between regulatory guidance and practical implementation. The session will address challenges unique to RWE settings, such as heterogeneous patient populations, complex treatment regimens, and the impact of intercurrent events on study outcomes with a focus on generating RWE that can inform regulatory decision-making. Through practical examples, case studies, and an engaging panel discussion featuring domain experts, this session will highlight best practices for defining estimands that enhance the interpretability and reliability of RWE findings. Participants will leave with a systematic approach to estimand definition, empowered to conduct RWE studies that are robust, actionable, and aligned with evolving regulatory standards.

This webinar will held virtually on June 5 2025 at 11:00 (EDT) / 16:00 (BST) / 17:00 (CEST)

The Integration of Omics Data into Clinical Drug Development project within the Emerging Trends & InnovationWorking Group has published a new White Paper titled “Capturing Computational Workflows in Clinical Trials with BioCompute”

This white paper explores how the BioCompute framework can transform the way computational workflows are captured and communicated in clinical trials. As bioinformatics analyses become increasingly complex, consistent and transparent documentation is essential for reproducibility and regulatory confidence. Through practical case studies, the paper demonstrates how BioCompute enables structured, auditable workflows across diverse data types, including omics and imaging, while supporting more efficient collaboration and regulatory submissions.

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.

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.

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.