| 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. |
Data Transparency Winter Event – 7-9 February
This year, the DT Winter Event will run across three days from 15:00 to 17:30 (GMT) and will feature live presentations, followed by a joint panel discussion/Q&A session. Find out whats in store by viewing the proposed agenda and click here to register!
Reimagining a Safety Submission – Aggregate Safety Assessment Planning – 16 February
The Safety Analytics Working Group will present their first ever Community Forum on 16 February 2023! Click here to register!
Recently Published Deliverables
Visit the PHUSE website to view the extensive list of all published deliverables.
The Educate the General Population project, part of the Data Transparency Working Group, aim to create engaging content that can be understood and used by the general population (any member of the public regardless of their sector or profession). The team have recently published two, out of a series of six, videos on data privacy and data sharing. The purpose of these videos is to answer frequently asked questions which will enable viewers to become more informed, thus helping to have a positive impact on their families and the wider community. The two videos are an Introduction and Importance of Clinical Trials. Please submit any feedback, to workinggroups@phuse.global.
If you would like to become a valued member of PHUSE and volunteer for one or multiple projects, please email: workinggroups@phuse.global.
The Nonclinical Topics Working Group is on the lookout for members to join the Conformance with the Tumor.xpt Specification project. The aim of this project is to create a non-exhaustive first set of technical conformance rules with the tumor.xpt specification. This project will provide the first set of validator rules to be implemented by tools already used by the industry for verification of SEND datasets, thus removing part of the current manual burden of reviewing this file.
Management of ODS Regulatory Referenced Deliverables: Do you have experience in creating any of the four regulatory referenced deliverables (cSDRG, ADRG, BDRG, SDSP)? The Optimizing the Use of Data Standards Working Group is looking for you to be a part of a new project to ensure these deliverables are kept up-to-date with regulatory guidance's. You will work with the ODS Working Group leads to coordinate updates as needed. To apply for this project, click here to submit an application form.
An exciting opportunity has arisen within the PHUSE Nonclinical Scripts project to collaborate with BioClelerate, the FDA and CDER for assistance with implementing the sendigR open-source package at your company. Collaborative team meetings will take place Fridays 8-9am EDT. Ideally, volunteers will have some programming experience (ie, python, unix/R) and some knowledge of internal SEND data storage. Click here for more information on the sendigR package and the benefits of working collaboratively.
| PHUSE/FDA CSS 2024 | ||||||
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Registration for the PHUSE/FDA CSS 2024 is 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.
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| Open Forum: Open Source in Pharma and Long-Term Dependability |
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The Open Source Technology in Clinical Data Analytics (OSTCDA) project is hosting an Open Forum on the topic of Open Source in Pharma and Long-Term Dependability with speaker Mike Smith. This forum will be taking place on zoom on 17 May 15:00-16:00 BST / 10:00-11:00 EDT. |
| New Deliverables |
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The Best Data Practices for Rare Disease Patient Foundations and Researchers within the Real World Evidence Working Group, has published a new deliverable in the form of a Poster. The Poster provides an overview of Ensuring Registry Data Relevance and Reliability for Regulatory Use. The PHUSE data standards community, which is comprised of leaders and experts responsible for the governance and implementation of data standards across the biopharmaceutical industry, have authored and new White Paper. The Data Standards White Paper highlights current challenges in data standardisation across the biopharma industry and identify opportunities where we can work together to tackle them. The SDTM ADaM Implementation FAQ within Optimizing the Use of Data Standards Working Group have published a new FAQ! The question they have answered is 'Naming Convention for Split RS Domain', you can view this question and the teams response viaValidation/Conformance Rules page. You can see all the FAQ this project has answered so far via here. Do you have a SDTM ADaM question? You can send your questions to the team by emailing workinggroups@phuse.global. The Quality Tolerance Limits project within the Risk Based Quality Management Working Group have published a new deliverable. The White Paper is on the topic of Assessing the Use of Quality Tolerance Limits in the Pharmaceutical Industry. This White Paper aims to provide the reader with valuable insights into the depth and breadth of the use of QTLs and addressing how QTLs are used in a wider scope of implementing RBQM. |
Calling for Feedback |
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| The Treatment Emergent Definitions Recommendations project within Safety Analytics Working Group has produced a White Paper 'Recommended Definition of Treatment-Emergent Adverse Events in Clinical Trials'.This document defines treatment-emergent events in Phase 1 to 4 clinical trials and integrated summary documents across therapeutic areas. The recommendations described herein were based on the authors’ collective experiences and a survey conducted by the PHUSE Treatment-Emergent Definition Recommendations project team [2] to solicit input from respondents on various TEAE scenarios for a simple clinical study design. Please provide your comments by emailing workinggroups@phuse.global. Closing date for comments: 7 June |
Volunteer Opportunities | |
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TheEstimands for RWD/RWE a new project within Real World Evidence Working Group is now calling for volunteers. The focus of this project is on best practices of RWD estimands, not on their implementation using data standards. The team formed would have representation from the PHUSE Implementation of Estimands (ICH E9 (R1)) using Data Standards project team, which has a white paper nearing publication as of 2024Q1, and the Estimands Implementation Working Group (EIWG) sub team on HTA and RWE, both with estimands expertise, along with representation from teams under the RWE Working Group. If you would like to volunteer or learn more about this project, email workinggroups@phuse.global. Closing date: 7 June 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. |
| Announcement |
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PHUSE Communications | |
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. |
| 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 |
Working Groups Latest Report Q3/4 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.
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