| 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, email: workinggroups@phuse.global. |
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| Working Groups Latest Report: Q12021 | This Report provides a detailed overview of the projects progress this past quarter. |
| Working Groups Events | |
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Enterprise Knowledge Graph supporting Business Improvement - Example with the Clinical Study Process Secure your place at the first-ever PHUSE Community Forum. This forum will be an informal, open discussion for the PHUSE Community to unite and discuss specific topics of interest. The first session is brought to you by the Emerging Trends & Technologies Working Group, and will be looking at knowledge graphs. Cedric Berger, Novartis, will lead the discussion with his experiences on how an enterprise knowledge graph enables to reconsider and significantly improve the process of designing, implementing, conducting a clinical study as well as cleaning, analysing and publishing collected data. By applying data management/governance 4.0, the process can be (semi) automated and dynamically adjusted to quickly adopt new business requirements. |  30th July 2021 at 15.00 (BST) Technical Conformance Guide & Test Data Submission to the eData FDA team Bring your questions to industry experts from across PHUSE and the FDA. This live event which is taking place on Friday 30th July 10:00 (EDT), will address questions from the industry on: The Study Data Technical Conformance Guide (TCG) The Technical Rejection Criteria (TRC). 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 Standardized 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. |
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Projects Calling for Participants Email workinggroups@phuse.global to get involved | |
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| A new project under the Data Visualisation & Open Source Technology Working Group is calling for volunteers. The R Environment System Qualification project is looking to develop scripts to qualify an R environment, including the base installation and additional R framework exists for the base installation tests. This project will collaborate with the RValidationHub and the RConsortium to gather requirements for R environments and best practices for qualifying R systems. | The Digital Biomarkers in Clinical Submissions project identifies current state of digital biomarkers in clinical sector and its future impact. It will cover the topics: Classification of existing digital biomarkers, Clinical Therapeutic areas where digital biomarkers usage is progressing, limitations, etc., Stakeholders impacted are Pharma, CROs, tech companies, regulators and SDOs. “DB360” will be built on the paper DH08 submitted in PHUSE US Connect 2020 with final outcome of White Paper and presentations at PHUSE conferences in 2022. |
| The PHUSE Nonclinical Topics Working Group is launching a new 5-week project to create example TS files, submit them to the FDA Test gateway, and publish the results. The team are looking to set up weekly meetings leading up to 30th June. Click here for more information on the scope of the project. | We are pleased to announce the launching of our 'NEWEST' Working Group Risked Based Monitoring. The Quality Tolerance Limits project are seeking volunteers to join the team. Now is a good time to get involved and help drive this forward from inception. |
The Internal Data Sharing team have put together a survey to gather feedback on internal data sharing practices, processes and procedures across the pharmaceutical industry. The feedback gathered in this survey will be summarised in a White Paper which will look to provide recommendations on internal data sharing processes, as well as identify similarities/differences between external and internal data sharing processes. This survey will close 29th June 2021. Thank you for your participation. | |
| 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 for template and submission. |
| Webinars | Events |
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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. |
Our PHUSE events are different in both nature and set-up. PHUSE events started back in 2004 with the inaugural PHUSE conference in Heidelberg. Since then, PHUSE has been organising events all over the globe. With that, we strive to meet the needs of our global community to share, advance and connect. All our events are aimed at different audiences. Click the banner above to see upcoming events. |
