Hot Topics

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.

Thats a wrap on the Data Transparency Winter Event 2023! PHUSE would like to thank all presenters, sponsors and attendees who helped to make this year's Winter Event a huge success. If you did attend, please complete the short feedback survey to share your thoughts on the event. If you did not get the chance to attend, all content is available to view on the PHUSE archive. 

Save the Date! The 2023 Data Transparency Summer Event will take place 20–22 June.

Reimagining a Safety Submission – Vision of Interactive Safety Reviews – 27 March
During this Community Forum, you’ll hear about various efforts related to interactive safety reviews. The presentation will be followed by a discussion on the end goal, potential impact on submissions, and different models for creating and sharing interactive safety review tools. Register here! 

Real World Evidence: Requirements and Recommendations for Regulatory Submissions – the Real World Evidence project is calling for feedback on their most recent White Paper. In this paper, the RWE project aims to provide an overview of the learnings, challenges, and best practices around RWD data sources, collection, cleaning, standardisation, reporting and regulatory submissions. This paper also aims to serve as a reference for relevant guidelines and articles related to the use of RWD/RWE for regulatory submissions. Please provide your comments directly into thedocument or send them to workinggroups@phuse.global by 20 March. 

The Nonclinical Topics Working Group is on the lookout for members to join the Conformance with the Tumor.xpt Specification project. The aim of this project is to create a non-exhaustive first set of technical conformance rules with the tumor.xpt specification. This project will provide the first set of validator rules to be implemented by tools already used by the industry for verification of SEND datasets, thus removing part of the current manual burden of reviewing this file.

Management of ODS Regulatory Referenced Deliverables: Do you have experience in creating the BDRG or SDSP? If so, then the Optimising the Use of Data Standards Working Group needs you! This recently formed project is on the lookout for new members to ensure regulatory referenced deliverables are kept up to date with regulatory guidance's and to carry out updates as needed. To apply for this project, click here to submit an application form.

Click here to view the additional projects within Working Groups which are open to join. 
If you would like to become a valued member of PHUSE and volunteer for one or multiple projects, please email: workinggroups@phuse.global. 

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, biologic 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. 

Working Groups Latest Report Q3/4 2022: The report includes project updates, recent and upcoming deliverables and the future plans for each Working Group.

Monthly Mailings: Our monthly newsletter. Here you will find a full update from each month of the year, easily accessible and divided into key areas of PHUSE.