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Real World Evidence

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)

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Information and Registration

Submit Abstract Here

Registration will open 17 June.

Data Transparency Autumn Event – Call For Speakers – Save the Date

The Data Transparency Working Group invites abstract submissions 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.

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

Click here for more information.

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We’re excited to announce Call for Speakers for the Submit Abstract Here

Registration will open 17 June.

Real World Data Autumn Event – Call For Speakers

Save the Date

Join us for the return of the Real World Evidence  Working Group’s second multi‑day virtual event is now open! Taking place 30 September – 1 October 2026, from on 30 September–1 October 2026. The event will run from 09:00–11:30 (EDT) / , 14:00–16:30 (BST) / 15, and 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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Nonclinical Topics – Calling For Feedback

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.

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