| 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. |
30th July 2021 at 15.00 (BST)
Technical Conformance Guide & Test Data Submission to the eData FDA team
During the live event we will address questions from the industry on, the Study Data Technical Conformance Guide (TCG), the Technical Rejection Criteria (TRC) and submitting test data to the FDA.
Please join our panel of PHUSE-appointed Subject Matter Experts (SMEs) from industry and the FDA, who will discuss their own experiences of submitting study data to the FDA eData (CBER and CDER) team and take questions from the audience.
As a pre-read to this event, please reference the TCG and TRC guidance. For information on submitting an eCTD or Standardised Data Sample to the FDA, please reference link. For further information on the Study Data Submission to CDER and CBER, click here.
Attendees are encouraged to submit their question in advance via this form, or at the event through the virtual event portal.
| 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. |
11th August 2021 at 15.00 (BST)
PHUSE/FDA Innovation Challenge Roadmap
We are excited to announce the PHUSE/FDA Innovation Challenge for 2022!
This will be a key highlight of the year with unparalleled learning opportunities and exposure to cutting edge problem-solving along the selected themes. Solutions will be presented during the US Connect 2022 in Atlanta, GA, 13–16 February.
Join this webinar to find out more and to hear the Innovation Challenge’s roadmap and the journey it will take from concept to challenges to solutions through our PHUSE/FDA CSS in September 2021 and the US Connect 2022.
This is also your exclusive opportunity to help shape the Innovation Challenge and submit challenge themes that can be solved through the work of the Challenge participants
6th August 2021 at 15.00 (BST)
Testing Simplified TS Examples Against FDA Technical Rejection Criteria for Nonclinical Studies
The Nonclinical Topics Working Group created a project to enable the industry to confidently know what TS files will be accepted and avoid a rejection. The results of this project will be described in this meeting.
The project results are important because:
2. Only sponsor organisations will receive warning messages between now and Q4, AND only if they have a submission between now and then.
3. Not all organisations involved in creating submission components will have the opportunity to create a test submission before the rejection criteria go into effect.
4. An organised test reduced the burden on the FDA compared to each organisation submitting test submissions.
This meeting will cover the test cases used, showing which passed and which failed. The test cases were assembled into one eCTD and submitted to the FDA test submission gateway. The eCTD was prepared as if it were a Commercial IND for CDER.
| Calling For Feedback |
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The Good Transparency Practices project within the Data Transparency Working Group, is now calling for feedback! This White Paper aims to define a set of best practices for data transparency and create a Good Transparency Practices guidance. The best practices will aim to ensure anonymised data is compliant with the legal requirements as defined by Regulators, as well as preserves as much data utility as possible. Please send in your comments to workinggroups@phuse.global by 3 May. |
| 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. |
Volunteer Opportunities | |
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The Data Visualisation & Open Source Technology Working Group has a new project, Demonstrating Real-World Impact of Modernization of Statistical Analytics (MSA) Framework.This project aims to extend the MSA framework by creating a reference architecture that takes into account real-world scenarios and design solutions to remediate them, ultimately providing a practical guide to building an end-to-end validated environment for regulated work. Companies seeking to build an open-source programming environment for regulatory reporting can leverage the MSA framework for guidance. However, since the framework is designed to be both flexible and extensible, implementing it may prove challenging for companies, resulting in situations where risks are not sufficiently mitigated. While the original MSA paper provided conceptual guidance, the PHUSE handover of the project will seek to provide an overview of practical implementations of the framework being applied. This project is calling for volunteers, to join contact workinggroups@phuse.global by 26 April. The Safety Analytics Working Group is looking for a new Working Group Lead to join their team. This Working Group is a cross-disciplinary collaboration working to improve the content and implementation of clinical trial safety analyses for medical research, leading to better data interpretations and increased efficiency in the clinical drug development and review processes. Click here to see a list of current projects within this Working Group. Learn more about the roles and the responsibilities of a Working Group Lead and apply by emailing workinggroups@phuse.global. Closing date 26 April. 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. |
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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Status colour Blue title Register Now
Projects Calling for Participants
Email workinggroups@phuse.global to get involved
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 |
Have you attended a PHUSE Webinar Wednesday?
They run throughout the year around the last Wednesday of every month and include presentations of hot topics in the industry and PHUSE.Click
to submit. |