| 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. |
| Data Transparency Autumn Event 2024 |
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Active since 2014, PHUSE’s Data Transparency Working Group has provided subject matter expertise for the review of draft deliverables and guidance documents from regulatory bodies (such as the EMA and Health Canada), as well as other industry organisations (such as TransCelerate) and academia. Since their inception in 2020, the free-to-attend Data Transparency Events have gone from strength to strength. These virtual events have created an unrestricted space where questions can be asked and challenges addressed. Individuals passionate about the area can come together to share vital knowledge, develop new ideas and spark innovation through presentations, panel discussions and Q&A sessions alongside experts in the data-sharing field. The PHUSE Data Transparency Autumn Event will take place from 17–19 September 2024. Data Transparency Events offer you the chance to gain knowledge and experience from a wide data transparency community, allowing you to come together with experts from a variety of companies and backgrounds. During this virtual event, presentations will be delivered across the three days in bitesize chunks from 15:00-17:30 (GMT). There will also be a panel discussion and Q&A session focused on the day's themes. The full event agenda can be found here. |
The Quality and Reusability of Real World Data project within the Real World Evidence Working Group has published its third Blog Post, RWD: The FDA’s Guidance on Assessing Registry Data to Support Regulatory Decision-Making. This Blog will explore the main messages in the regulatory guidance, what challenges we foresee in applying it, and how registry data can be used in regulatory applications. You can learn more about this project and read their previous blogs here. |
| The Risk Based Quality Management Working Group has a new Working Group Lead. Mireille Lovejoy currently serves as Director, Clinical Risk Management and Process Excellence at GE HealthCare, a role dedicated to the design and implementation of Risk Based Quality Management (RBQM) and quality at the system level within diagnostic clinical trials. |
| Mireille has extensive experience of RBQM having previously led the development of processes, resources, and technology underpinning the approach within 2 bio-pharmaceutical companies. |
| Calling for Feedback |
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The AE Groupings in Safety (AEGiS) project within the Safety Analytics Working Group has produced a White Paper, 'Utilization of Adverse Event Groupings in Clinical Trial Safety Assessment' This document outlines why using standard AE groupings for queries is key to understanding a drug's safety profile, discusses some assumptions underlying use of standard queries for estimation and outlines the benefits of standard queries when available. When standard queries are not available but detailed analysis of a specific medical condition is needed, this document recommends a process to develop and maintain a custom query that can be replicated by regulatory authorities. Please provide your comments by emailing workinggroups@phuse.global. Closing date for comments: 6 September. |
TheOpen Source Technology in Clinical Data Analysis (OSTCDA) projectis hosting an Open Forum called What is the True Cost of Open Source.This forum will hear from Mike Stackhouse, who will cover a range of topics related to the following questions:
This Forum will be taking place over Zoom on 13 September at 15:00-16:00 (BST) / 10:00-11:00 (EDT). |
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. |
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. |