| 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. Share your insights, discoveries and solutions with the PHUSE Community, who are eager to learn and collaborate.
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| 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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‘Data Integration & Submission Challenges’ – bring your questions to industry experts from across PHUSE, CDISC and the FDA
It is a struggle for sponsors to establish an integration strategy using standardised data and legacy data at the tabulation and/or analysis level as no specific strategy or requirements exist within the industry or from regulatory agencies. The industry continues to face challenges and hurdles with pooling, levelling, traceability, and compliance checks with regards to integration. There are currently no published industry-defined data standards for the submission of an ISS/ISE. PHUSE has also initiated a new project to develop a template, completion guidelines and example documents for an integrated DRG.
The live event addressed questions from the industry on the challenges around data integration and submission of electronic data to the regulatory agencies.
Click here to watch the webinar on demand and view the presentations.
The Data Transparency Summer Event will run for 2.5 hours each day 15:00–17:30 (BST).
22nd–24th June 2021
PHUSE has established itself as the world’s largest home for data transparency events. If you are passionate about advancing this fast-moving field, then this is the event for you.
Join an innovative, informative and inclusive space where knowledge is shared across all Pharma companies, vendors and software companies. The event looks to meet the ongoing needs of data transparency within the clinical development arena and will showcase thought-provoking presentations from industry leaders.
Attendees will have the opportunity to listen to three live presentations and then participate in a joint panel discussion/Q&A session based on the content from the day.
Registration and Call for Speakers is now open! Click here for more information.
Projects Calling for Participants
The Optimizing the Use of Data Standards Working Group is actively seeking a new Project Co-Lead for the Bio-research Monitoring Data Reviewer’s Guide (BIMO) initiative. This role will be working alongside Julie Maynard. Here you will find an overview of the project scope together with an outline of their deliverables and timelines. This is a NEW project, so now would be a great time to get involved and have a real impact on the outcomes.
Click here for more information on the role and how to apply. Closing date for applications is Friday 9th April
The Emerging Trends & Technologies Working Group is actively seeking new members to work on the FHIR team initiative. Here you will find an overview of the project scope together with an outline of their deliverables. The team are currently reviewing these and adapting their timelines accordingly, so now would be a great time to get involved.
If you're interested in getting involved contact workinggroups@phuse.global.
The Synthetic Data Project will be hosting five 90-min training sessions on a monthly basis until July. Hosted by Replica Analytics, the training sessions will review different techniques and explore different use cases relevant to the Life Sciences industry. During the time leading to July, the project team will elaborate on the first deliverable to focus on following the end of the training period. If you want to sign up to the Data Synthesis project and gain access to the PODR, please contact workinggroups@phuse.global. Registration for the 1st April event is now open.
Project Idea?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 |
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 here to register and view previous presentations. 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 membership to share, advance and connect. All our events are aimed at different audiences. Click the banner above to see upcoming events
to submit. |