| 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. |
| Community Forums |
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The Emerging Trends & Technologies Working Group is hosting a Community Forum where speaker Dr. Junshui Ma, Merck who will be using his experience in pharmaceutical R&D to speak on the Innovations in Healthcare in the Age of Generative AI and will illustrate how generative AI is empowering every innovative mind. This forum will be taking place over Zoom on 17 April 14:00–15:30 (BST) / 09:00–10:30 (EDT). The Real World Evidence Working Group will be hosting a Community Forum called Meet the Real-World Data Provider. This forum will hear from three speakers Michèle Arnoe, IQVIA, Jeffrey Brown, TriNetX and Benjamin Forred, Sanford Research who will cover a range of topics related to data provision, including the challenges associated with delivering data to the end user and the various ways in which the data provider can assist. This forum will take place on 18 April 14:00–15:00 (BST) 09:00–10:00 (EDT). |
Volunteer Opportunities | |
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The Optimizing the Use of Data Standards Working Group is looking for a new Working Group Lead to join their team. Over the last decade, the development and adoption of data standards have shown significant promise in improving the efficient delivery of data to support drug product and device submissions as well as the review process. However, there have also been gaps, issues and challenges in the interpretation and use of data standards. The goal of this Working Group is to work together to identify and close those particular gaps that impede industry and the FDA from making the most efficient use of data standards. 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 29 March. The Nonclinical Topics Working Group has initiated a new Project called ‘Supporting the Use of SEND for the Implementation of Virtual Control Groups’ which is now calling for volunteers! This project will leverage the deep SEND knowledge and experience of the PHUSE Nonclinical Topics Working Group by initially focusing on the development of best practices with respect to population of SEND datasets with data from virtual control animals. This project will be working alongside the Nonclinical Scripts project also within the Nonclinical Topics Working Group and provide an open venue for the socialisation and hosting of open-source software solutions related to selection procedures and database infrastructure. If you are interested in joining, please contact workinggroups@phuse.global. Closing date 13 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. |
| BIMO FAQ Forum Global Survey |
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Do you have a question relating to Bioresearch Monitoring (BIMO)? The Bioresearch Monitoring (BIMO) Frequently Asked Questions Forum project within the Optimizing the Use of Data Standards Working Group are here to help. You can find all previous BIMO questions and answers published here. Instructions for submitting your questions via the BIMO FAQ Survey:
We look forward to receiving your BIMO questions! |
| SDTM ADaM Questions |
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The SDTM ADaM Implementation FAQ project within Optimizing the Use of Data Standards wants to answer more of your SDTM ADaM questions! There are many questions related to data submissions requirements by various regulatory agencies around the world (e.g. FDA, PMDA, NMPA). The project's team currently: 1. Collect frequently asked questions (FAQs) from Industry. 2. Assess the appropriateness of a question, develop and review a response, collaborate with CDISC/FDA for clarity if required. 3. Publish the FAQ and responses on the Advance Hub database for helpful implementation/strategy information. If you have any questions for the team, please contact: workinggroups@phuse.global. You can find the previous questions that have been answered on the project page, under Objectives & Deliverables. |
| 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. |
PHUSE Communications | |
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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. |
