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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, email:

Working Groups Latest Report: Q3/42021This Report provides a detailed overview of the projects progress this past quarter.

Working Groups Events 

PHUSE's fourth Data Transparency Event will take place 8–10 February 2022.
Consisting of 2.5 hours each day (15:00–17:30 GMT), there will be live presentations and a joint panel discussion/Q&A session based on content shared in this fast-moving field of clinical development.

CLICK HERE for more information.

Visit the Working Groups Events page to view all previous event material on-demand. 

Projects Calling for Participants 

Email to get involved

Good Transparency Practices – Project Co-Lead and Members

The project aims to define a set of best practices for data transparency and create a Good Transparency Practices guidance. The best practices will help ensure anonymised data is compliant with the legal requirements, as defined by regulators, as well as preserving as much data utility as possible. 

Treatment Emergent Survey

The PHUSE Treatment Emergent Definition project team has goals of reducing variation in treatment emergent definitions and better harmonizing industry practice. The group developed a survey to collect input on various treatment emergence scenarios and it will play a key role in meeting their objectives. The survey launched in mid-August and to date the group have had approximately 230 respondents. Unfortunately, only 1 person from a regulatory agency has participated so far. The group invite more input from our regulatory colleagues before the survey closes on the 18 February and would appreciate your help with soliciting for more participants from the FDA. 

Deliverables Calling for Feedback 

PHUSE's BIMO project team have prepared a final draft version of the BIMO Data Reviewers Guide Package.

The purpose of this is to allow up front communications to the FDA regarding sponsor’s consideration and deviations from the latest BIMO Technical Conformance Guide (TCG) and, in an effort to avoid the Information Requests that are currently issued by the agency to sponsors, to address inconsistencies between sponsor’s interpretation of BIMO TCG, format and content of Bio-research Monitoring Data Reviewers Guide. 

The team is respectfully calling for public feedback on the package which includes a BDRG template, completion guideline and examples. Before reviewing these documents, please read through the BDRG introduction and overview. Please submit any feedback to by 15 February using the BDRG review feedback tracker to log your comments.

The Harmonization of SEND Implementation to Enable Historical Control Data Analysis team has drafted a White Paper which looks to propose harmonization for SEND Trial Summary (TS) and Trial Set (TX) parameters that are used to identify the names and locations of Test Facilities, Test Sites, and Test Subject Suppliers. 

The team is calling for public feedback on the White Paper. Please submit your feedback to by 15 February. 

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

Webinars Events 

Have you attended a PHUSE Webinar Wednesday?

They run throughout the year around the last Wednesday of every month and include presentations of hot topics in the industry and PHUSE.

Click here to register and view previous presentations. 

Our PHUSE events are different in both nature and set-up. PHUSE events started back in 2004 with the inaugural PHUSE conference in Heidelberg. Since then, PHUSE has been organising events all over the globe. With that, we strive to meet the needs of our global community to share, advance and connect. All our events are aimed at different audiences. Click the banner above to see upcoming events. 

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