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 |
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The 12th PHUSE/FDA Computational Science Symposium took place 18–20 September 2023. The event was a great success with 210 attendees from across industry, academia and regulatory agencies! Please visit the summary page for some more information and dates for next year and the summary video is now live to view. |
Safety Analytics Webinar Series: Interdisciplinary Safety Evaluation for Learning and Decision-Making |
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The Safety Analytics Working Group will be delivering a series of virtual, free to attend webinars over the coming months. The fifth and final webinar will take place 16 November 15:00 – 16:45 (GMT) 10:00 –11:45 (EST) on the topic of 'Education for Executives', registration will open 19 October. A list of all upcoming webinars and previous webinars can be found here. |
Real World Evidence Community Forum: Experiences with Adapting RWD to CDISC Submission Standards |
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The Real World Evidence Working Group will be hosting another Community Forum, 5 October 14:00–15:00 (BST) 09:00–10:00 (EDT). Presentations will be on the topic of 'Experiences with Adapting RWD to CDISC Submission Standards'. During this Community Forum, presenters will share their experiences and the challenges they encountered along with the solutions they came up with when working with RWD and CDISC standards. Register here! |
Deliverables |
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NEW SDTM ADaM Implementation FAQ question has been added to their Data Submission page, have a look to see the new and previous FAQs from the project so far. The Centralised Monitoring Capabilities project within the Risk Based Monitoring Working Group have just published their White Paper: http://Can the Value of Centralised Monitoring Be Quantified? and the Survey Results. This White Paper dives into the results of the projects own industry survey and examines the benefits and limitations of Centralised Monitoring and other traditional monitoring strategies. |
Volunteer Opportunities | |
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The Safety Analytics Working Group's new project, Interactive Analyses and Displays for Laboratory Data is now are calling for volunteers. This project aims to bring together stakeholders from pharma, academia, and regulatory bodies with diverse backgrounds, such as statisticians, clinicians, medical experts, and programmers. The goal is to collaborate on a deliverable concerning the use of interactive displays in the assessment of laboratory data during phase 2-3 clinical trials. The deliverable will be a specification document providing platform-agnostic recommendations to stakeholders about the features and options that should be considered for interactive displays of laboratory data. This project’s scope will encompass considerations for interactive visualizations used in ongoing safety monitoring, regulatory submissions, and publications. Real World Evidence Working Group’s new project, Real World Data Guideline/White Paper for Statistical Programmers is now calling for volunteers. The aim of this project is for statistical programmers across pharma to collaborate and provide their input to create an RWE Guideline/White Paper for the industry. Data Transparency Working Group's new project Anonymization of Imaging Data is now calling for volunteers. This project plans to complete a literature review on types of imaging files including (X-rays, (f)MRIs, CT scans, etc.), their formats (DICOM, NIfTI, etc.), their positions (limbs, heads, organs, etc.) and all associated metadata. There will also be a discussion on data handling, storage and transfer. Any existing guidance and repositories will be reviewed. We will then focus on use cases that will have the most impact based on interest and complexity. Please contact workinggroups@phuse.global to register your interest in volunteering. | |
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, 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 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 bought to you by industry professionals. |