| 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 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. |
The Safety Analytics Working Group will be delivering a series of virtual, free to attend webinars over the coming months. The fourth webinar will take place 4 October on the topic of 'Interactive Safety Graphics for Regulatory Decision-Making'. Click here to register, 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
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!
Announcements
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.
| 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 |
Volunteer Opportunities
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.
The Quality tolerance Limits Project, within the Risk Based Monitoring Working Group is currently looking for a new co-Lead. The team are working on developing a white paper which is analysing the results of their recent survey. The project aims to define role of QTLs in QbD, in particular the relationship to CTQs (Critical to Quality Factors), Estimands and continuous quality improvement (CQI), Discuss the use of QTLs in Early Development/small studies, bio equivalence and complex designs Discuss examples of how to define QTLs, different methodologies and different parameters in use across the industry, Discuss difficulties and challenges of implementation of QTLs and Examine role of QTLs as part of the of the lessons learned (RCA) feedback loop.
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. |
| Announcement |
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PHUSE Communications | |
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:
- The projects must address significant research issues relevant to Computational Science
- The project must not attempt to address FDA policy issues
- There must be at least one Project Lead personally involved in planning and carrying out the project
New projects can be submitted anytime during the year, click here to submit.
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 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 bought 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. |