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 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! |
October Community Forum | ||
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Reg now open! The Emerging Trends & Technologies Working Group presents the next Community Forum: Ingestion and Standardization of Real-World Data. |
Recently Published Deliverables |
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Visit the PHUSE website to view the extensive list of all published deliverables. |
The Analyses & Displays for Laboratory Data project (Safety Analytics) has recently published a White Paper with recommendations for analyses and displays for laboratory data, with a focus on Phase II to IV clinical trials and integrated submission documents. There have been two previous white papers (2013 and 2015). The latest white paper (August 2022) provides updated recommendations. You can view the White Paper here. |
The SDTM ADaM Implementation FAQ project, part of the Optimizing the Use of Data Standards Working Group, has published a new response to a question they received under SDTM/ADaM IG Nuances. The question is based on the handling of transgender patients in clinical trials. |
Projects Calling for Volunteers |
For information on the PHUSE Working Groups and their projects, click here. |
The Office of New Drugs (OND) in the FDA Center for Drug Evaluation and Research (CDER) will release documents for public review on standard adverse event groupings and queries for evaluation of biologic/new drug applications. |
Best Data Practices for Rare Disease Patient Foundations and Researchers, part of the Emerging Trends & Technologies Working Group, is looking for members to join their project to create a guidance about best data practices for patient foundations and for researchers in the form of decision trees, graphics, short printable materials or videos. Please contact workinggroup@phuse.global for more information. |
Project Idea? |
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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:
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. |