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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.

CSS: This year's PHUSE/FDA CSS from the 19-21 September will take place at the Civic Centre, Silver Spring, MD . 

The three days will focus on Working Group activities, a highly successful poster session and several networking events. A regulatory plenary session will take place where we will hear from the FDA and EMA regarding data. In addition to these presentations, there will also be two sessions relating to the Office of New Drugs release of standard tables and figures and standard adverse event groupings and queries! There will be two workshops held over the three days, for more information take a look on the PHUSE website where you can find the full agenda and how to register!

The Central Monitoring Capabilities project, under the Risk Based Monitoring Working Group have drafted a White Paper titled: Centralized Monitoring: Exploring the Considerations and Challenges of Implementation. The paper describes common obstacles to implementing centralized monitoring (CM), while providing insight and guidance to address those difficulties to enable CM to be a key component to a successful risk based monitoring approach. It covers topics such as CM implementation models, CM change management, the central monitor role, and the execution of CM activities. The team is respectfully calling for public feedback on the White Paper. Please submit any feedback by 6 September to workinggroups@phuse.global.

The Safety Analytics Working Group, are looking for members to join a project to provide consolidated PHUSE feedback on the standard tables and figures and standard adverse event groupings and queries packages, for more information see here. If you are interested in joining the team please email workinggroup@phuse.global.

For information on the PHUSE Working Groups and their projects, click here.

AE Groupings in Safety (AEGiS) – Project Members

The PHUSE Safety Analytics Working Group is launching a new cross-disciplinary project team: AE Groupings in Safety (AEGiS). As noted in the FDA Clinical Review Template (Section 7.1.2 in Attachment B) and the EU SmPC Guideline and emphasised in the 2017 PHUSE adverse events white paper, adverse event categorisation that is too granular can result in underestimation of an event (e.g. somnolence, drowsiness, sedation and sleepiness probably all refer to the same event). This project team will develop points to consider when deciding whether to use a MedDRA-defined grouping of PTs versus creating a custom grouping and will provide recommendations on process/implementation (maintaining custom groupings, analysis planning, ADaM development, tables and figures). Note this project team will not be creating any custom groupings. Final deliverables may include presentations at scientific conferences, publishing a white paper and/or publishing in a peer-reviewed journal.

If you are interested in participating in this project, please email workinggroups@phuse.global. 

Working Groups Latest Report Q2 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.