| 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. |
| PHUSE/FDA CSS 2024 |
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Registration and Call for Posters for the PHUSE/FDA CSS 2024 is now open! Come and be a part of the PHUSE/FDA Computational Science Symposium 2024 (CSS) taking place 3–5 June in Silver Spring, MD. Share your insights, discoveries and solutions with the PHUSE Community, who are eager to learn and collaborate. Sponsored by Entimo, the Poster Session will take place on Tuesday 4 June. Seize this opportunity and submit a 150-word abstract by 8 March. Be sure to register by 15 March to use the PHUSE Early Bird discount! |
Data Transparency Winter Event 2024 |
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The PHUSE Data Transparency Winter Event will take place from 6–8 February 2024. The Data Transparency Event offers you the chance to gain knowledge and experience from a wide data transparency community, allowing you to come together with expects from a variety of companies and backgrounds. During this virtual event, presentations will be delivered across the three days in bitesize chunks from 15:00-17:30 (GMT). There will also be a panel discussion and Q&A session focused on the day's themes. To view the agenda and full event information, visit the event page. |
| Risk Based Quality Management - The Risk Based Management Feedback Loop Community Forum |
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The Centralised Monitoring Capabilities project within the Risk Based Quality Management Working Group is hosting a Community Forum on the The Risk Based Monitoring Feedback Loop. This will be an interactive session with Vera Pomerantseva who is an Associate Partner, Risk and Quality Management Lead at ZS Associates. The forum will discuss the journey of the risk signal communication, the experiences and challenges that occur in the process. This Community Forum will take place over Zoom, 21 February 15:00 - 16:00 GMT / 10:00 - 11:00 EST. |
| Calling for Feedback |
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The Adverse Event Collection Recommendations project within the Safety Analytics Working Group has produced a White Paper 'Adverse Event Collection Recommendations' which provides recommendations for Adverse Event Collection Instructions, with a focus on Phase 2-4 clinical trials. The team are calling for your feedback! Please provide your comments by emailing workinggroups@phuse.global. Closing date for comments: 14 February. The SEND Industry Feedback Survey Project, within the Nonclinical Topics Working Group have published their 2024 survey! The survey will be live until 23 February with questions on the topics of manual edits, progress on new implementation guides and harmonisation of current SEND initiatives. This is an anonymous survey and the information gathered will be shared at the upcoming PHUSE/FDA CSS 2024. The Risk Based Monitoring Working Group has changed to Risk Based Quality Management. With a wider remit focused on RBQM, this Working Group will identify innovative approaches in the planning (Quality by Design, Critical to Quality, Risk Identification and Characterisation), conduct (Risk Control), and continuous improvement (Risk Review, Risk Communication) elements of RBQM that support proactive management data reliability and participant well-being. The leads have produced a survey so you can have your say in the evolution of this Working Group! Please complete this survey by the 6 March. |
| SDTM ADaM Questions |
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The SDTM ADaM Implementation FAQ project within ODS are wanting to answer more of your SDTM ADaM questions! There are many questions related to data submissions requirements by various regulatory agencies around the world (e.g. FDA, PMDA, China FDA). The project's team currently: 1. Collect frequently asked questions (FAQs) from Industry. 2. Assess the appropriateness of a question, develop & review a response, collaborate with CDISC/FDA for clarity if required. 3. Publish the FAQ and responses on Advance Hub database for helpful implementation/strategy information. If you have any questions for the team, please contact: workinggroups@phuse.global. You can find previous questions that have been answered on project page, under Objectives & Deliverables. |
Volunteer Opportunities | |
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The Risk Based Quality Management Working Group have just initiated a new Project called 'OpenRBQM: Pre-Competitive Collaboration on Open-Source Software for RBQM' which is calling for volunteers! They will form an Open-Source TBQM Working Group and an associated development sub-team. If you are interested in joining, please contact workinggroups@phuse.global by 6 March. Multiple projects within Working Groups are open to join. PHUSE welcomes new members who can apply their knowledge to bring fresh ideas and contribute to the ongoing work of PHUSE projects. For more information, click here, read the Welcome Pack or email workinggroups@phuse.global. |
| New 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, biological 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 | |
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Working Groups Report: Includes project updates, recent and upcoming deliverables and the future plans for each Working Group. | |
Monthly Mailings: The 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 brought to you by industry professionals. |
