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| 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. |
| Safety Analytics Webinar: Recommendations for Adverse Event Collection and Treatment Emergent Definition |
Recommendations for Adverse Event Collection and Treatment Emergent Definition In 2019, the PHUSE Best Practices for Data Collection Initiatives project team, in conjunction with the Analysis and Display of Safety Analytics project team, conducted a survey to study the variation in the collection and definition of treatment emergent adverse events (TEAEs) in clinical studies. It noted the need to pursue additional research to further harmonise industry practices. The PHUSE Adverse Event Collection Recommendations and the Treatment Emergent Definitions Recommendations project teams were formed to develop recommendations to reduce the implementation variability. Adverse Event Collection Recommendations: The PHUSE Adverse Event Collection Recommendations project team developed recommendations for the collection of adverse events which aim to improve the quality of the data and the site experience, as well as provide the data for treatment emergent definitions and for recommended analyses and displays. Earlier this year, the project team issued a white paper documenting the recommendations. This webinar will provide an overview of the white paper, including time for Q&A. Treatment Emergent Definitions Recommendations: The PHUSE Treatment Emergent Definitions Recommendations project team conducted a survey to solicit input from industry and regulatory respondents on various TEAE scenarios for a simple clinical study design. The project team developed a white paper with recommendations for standardising the TEAE definition based on the survey results, as well as their collective experiences. This webinar will provide an overview of the white paper, including time for Q&A. This webinar will be taking place over Zoom on 20 November at 15:00-16:30 (GMT) / 10:00-11:30 (EDT) / 16:00-17:30 (CET). |
| Community Forum: Responsive Regulation of AI in Drug Development |
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Responsive Regulation of AI in Drug Development The use of artificial intelligence (AI), including machine learning (ML), technologies across all stages of the drug product life cycle may accelerate the delivery of safe and effective high-quality drugs. As this data-driven technology continues to rapidly evolve across the landscape of drug development, a responsive regulatory approach may be warranted to calibrate the requirements needed to meet safety and evidentiary standards. This responsive regulatory approach can be based on an assessment of model risk, which is estimated by examining AI models’ influence on regulatory decision-making and the potential consequences of wrong decisions if the model is inaccurate. This responsive regulatory approach is rooted in an in-depth understanding of the specific application context and calibrates regulatory requirements in accordance with model risk. Principles of trustworthy and responsible AI serve as the foundation for responsive policy development and provide valuable considerations for both AI tool developers and regulators. It is important to consider ways to continue to engage with all interested parties to remain responsive to the changing technological landscape. Scientific discussion around continuing our responsive risk-based regulation, our collaborative efforts across the AI ecosystem (i.e. academia, industry, biotech), and advancing regulatory science in this area, without adding unnecessary burden to developers or regulators, is warranted. This webinar will be taking place over Zoom on 21 November at 14:00-15:30 (GMT) / 9:00-10:30 (EDT) / 15:00-16:30 (CET). |
| Final Webinar Wednesday of the Year |
Join us for the final Webinar Wednesday of the year! Don’t miss an exclusive presentation from the Safety Analytics Working Group, where AEGiS Project Leads Peg Fletcher, MedAssessment, and Mac Gordon, Johnson & Johnson, will discuss their latest findings and share insights from their upcoming published White Paper. The webinar will also feature exciting updates and ways to get involved with PHUSE in 2025, a live recap of the EU Connect 2024, and a presentation on bringing Open Source R into mainstream use for CDISC SDTM. Do you have questions for the AEGiS team but can’t attend? Send them to workinggroups@phuse.global, and they’ll be answered live during the Q&A! Then, you can watch the webinar on-demand to catch the answers at your convenience. This webinar will be taking place over Zoom on 27 November at 15:00 (GMT) / 10:00 (EST) / 16:00 (CET). |
| Data Transparency Winter Event 2025 |
Call for Speakers has closed for the Data Transparency Winter Event 2025! Taking place virtually 4-6 February, this event presents an incredible opportunity to showcase your ideas, share insight and engage with a vibrant community dedicated to advancing data transparency in the industry. Abstracts are currently being reviewed and the agenda drafted, watch this space for exciting agenda announcement's coming soon! |
| Announcement - Emerging Trends and Technology Working Group Is Changing It's Name to Emerging Trends and Insights |
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The "Emerging Trends and Technology" (ET&T) Working Group is changing its name! This Working Group will now be called "Emerging Trends and Insights" (ET&I). Hear from one of the Working Group's Leads, Mike Hamidi, on why they are making this change: "The proposed name change from Emerging Trends & Technologies to Emerging Trends & Insights reflects a broader focus beyond just technological enablement. This shift encompasses not only ongoing developments in areas such as AI/ML, digital health technologies, and healthcare standards but also aims to provide deeper insights into these and other evolving topics. We believe this adjustment will preserve the emphasis on emerging trends while enhancing our commitment to delivering valuable industry insights." |
| Announcement - PHUSE/FDA CSS 2025 |
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In its 14th year, the PHUSE/FDA Computational Science Symposium (CSS) will be expanding its global reach! In addition to Silver Spring, Maryland, we will be running a simultaneous event in Utrecht, the Netherlands! Mark Your Calendars! The US event will be in Silver Spring, Maryland 19-21 May, and the EU event will be in Utrecht, the Netherlands 20-21 May. Please visit the PHUSE website for more information. |
If you would like to get involved in a PHUSE Working Group Project, please explore the projects via the Working Group Tabs and contact the PHUSE Office on workinggroups@phuse.global to express your interest. |
| The AE Groupings in Safety (AEGiS) project within the Safety Analytics Working Group has published a new white paper. This white paper outlines why using standard AE groupings for queries is key to understanding a drug’s safety profile, discusses assumptions underlying the use of standard queries for estimation and outlines the benefits of standard queries when available. When standard queries are not available, but detailed analysis of a specific medical condition is needed, this document recommends a process to develop and maintain a custom query that can be replicated by regulatory authorities. |
| The SDTM ADaM Implementation FAQ project within the Optimizing the Use of Data Standards Working Group has published four new FAQs! They have answered three FAQs relating to SDTM/ADaM IG Nuances and have answered the first FAQ within a brand new category, SDTM/ADaM Harmonisation. You can view all categories and see the FAQ's this project has answered so far via here. Do you have a SDTM ADaM Implementation FAQ question? You can send your questions to the team by emailing workinggroups@phuse.global. |
The Best Practices in Data Standards Implementation Governance project within the Optimizing the Use of Data Standards Working Group has published a new white paper. This white paper presents the results of the survey along with feedback from informal discussions at the PHUSE/FDA Computational Science Symposium (CSS) sessions in 2022 and 2023. The data and observations shared are intended to inform industry and identify further projects for exploration while also encouraging industry collaboration for areas which are found to be the most challenging. |
Working Groups Report: Includes project updates, recent and upcoming deliverables and 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 a 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. |
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. |