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pharmaverse

pharmaverse Hackathon Series Featuring the {xportr} Package
Hackathon

Kick-Off – 12 May 09:00–10:00 (EDT) / 14:00–15:00 (BST) / 15:00–16:00 (CEST)
Hackathon

– 21 May 08:00–10:00 (EDT) / 13:00–15:00 (BST) / 14:00–16:00 (CEST)
Hackthon Wrap Up – 28 May 09:00–10:00 (EDT) / 14:00–15:00 (BST) / 15:00–16:00 (CEST)

Info

Information and Registration

Real World Evidence

Risk Based Quality Management

Webinar

: Biostatistical Considerations When Using RWD and RWE in Clinical Studies for Regulatory Purposes21 May 11

: Quality Tolerance Limits (QTLs): Setting the Threshold

23 June 10:00-

12

11:00 (EDT) /

16

15:00-16:00 (BST) /

17

16:00-

18

17:00 (CEST)

Info

Information and Registration

Data Transparency Autumn Event – Save the Date

The Data Transparency Working 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.

Registration will open 17 June.

Real World Data Autumn Event – Save the Date

Join us for the return of the Real World Evidence Working Group’s multi‑day virtual event on 30 September–1 October 2026. The event will run from 09:00–11:30 (EDT), 14:00–16:30 (BST), and 15:00–17:30 (CEST).

Registration will open 17 June.

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Nonclinical Topics – Calling For Feedback

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The SEND Industry Feedback Survey project, under 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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, is looking for volunteers to support this exciting initiative.

This project will help gather valuable industry insights and feedback to support future discussions and improvements within the SEND space. If you are interested in contributing, collaborating with peers, and helping shape this project, we’d love to hear from you.

Find out more information about the project on the Volunteer Board. To get involved, please complete the New Member Onboarding Form.

Info

New Member Onboarding Form

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. 

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