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Working Groups 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.

CSS 2022
CSS: This year's PHUSE/FDA CSS takes place 19-21 September. To find out more, take a look at the agenda on the PHUSE website. Don't miss out, click here to register! 

Data Transparency Summer Event 2022

Data Transparency Summer Event: Thank you to all of our presenters and attendees for once again ensuring the Data Transparency Summer event was a great success! Couldn't attend? Not a problem! Click here to visit the PHUSE Engagement Hub where you can catch up on all previous online events. 

     Community Forum

The Role of the Statistician and Statistical Programmer in Real-World Data Analysis: The Real World Evidence project, part of the Emerging Trends & Technologies Working Group, hosted the most recent PHUSE Community Forum which took place 6 July. This meeting began with a 30-minute presentation focused on the changes necessary to use real-world data. Its not too late to get involved! Catch up on the recording and join the discussions over on the online Disqus Forum. Chat with like minded individuals on how the changes affects the role of the statistical programmer and the statistician. 

Save the date! – 5 October 2022
The Emerging Trends & Technologies Working Group once again presents the next Community Forum: Challenges in Real World Data Ingestion and Standardization. 

Recently Published Deliverables

If you wish to view the extensive list of all PHUSE published deliverables, click here. 


Deliverable Calling for Feedback 

The Cloud Adoption in the Life Sciences Industry project, under the Emerging Trends & Technologies Working Group has updated the Audit appendix to main document - A Framework for Adoption in the Regulated Life Sciences Industry. The appendix describes the approach to audit activities or similar to cloud service providers in scope of GxP. It covers topics such as Regulatory Requirements for Auditing, General Audit Activities in the Cloud Supply Chain and Data Integrity. The team is respectfully calling for public feedback on the White Paper. Please submit any feedback by 23 August to workinggroups@phuse.global.  

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.

Projects Calling for Volunteers

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. 

Project Idea?

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. 


PHUSE Communications 

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.

PHUSE Blogs: Fancy a quick read? A blog is the 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 bought to you by industry professionals. 


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