| 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. |
| Open Source – Open Source in Pharma, Regulatory Acceptance and Validation |
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Registration for the Open Source Open Forum is open! The Open Source Technology in Clinical Data Analysis (OSTCDA) project is hosting their fourth Open Forum: Regulatory Acceptance of Open-Source Submissions, they will be addressing the following questions:
Come and be a part of our next virtual Open Forum on 12 July at 15:00(BST) 10:00(EDT). |
The Quality and Reusability of Real World Data project within Real World Evidence, has published two new Blogs! The 'Understanding the Data Quality Issues in Real-World Data Through Real-World Examples', blog takes a closer look at the experiences shared within the dedicated Working Group in exploring the types of data quality hurdles encountered when using Real-World Data (RWD). The 'Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products' blog explores the use of Real-World Evidence (RWE) as a powerful tool for informing regulatory decisions and advancing medical innovation. 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 Educate the General Population on Data Privacy and Data Sharing project, within the Data Transparency Working Group has published video 2 of their series. The 'What Will I Receive and When Will I Receive It?’ The video covers topics such as the concept of consent to participate in a clinical trial, an overview of trial design and treatment procedures to develop a strong foundational understanding of clinical trials. To view the full series of videos created by this team, visit the PHUSE website. |
The Enhanced Risk-based Quality Management (RBQM) Approaches for First-in-Human and/or Small Clinical Trials a new project within Risk Based Quality Management Working Group is now calling for volunteers. This project aims to to discuss and focus on a robust strategy/process and best practices for:
If you would like to volunteer or learn more about this project, email workinggroups@phuse.global. Closing date: 5 July 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. |
The Safety Analytics Working Group are pleased to welcome two new Leads to the team: Mac Gordon and Ellis F Unger. Mac Gordon has a master’s in statistics and graduate certificates in public health, pharmacovigilance and pharmacoepidemiology and has been with Johnson & Johnson for 15 years and in industry for 20 years and Ellis is a board-certified cardiologist, who retired from the US Food and Drug Administration following a 24-year career, where he served in senior leadership roles in the Office of New Drugs, Center for Drug Evaluation and Research (CDER). They will be joining the current Leads Mary Nilsson, Greg Ball and Scott Proestel, you can learn more about the new leads via the Safety Analytics page. The Optimizing the Use of Data Standards Working Group are pleased to welcome two new Leads to the team: Sandra VanPelt Nguyen and Edwin van Stein. |
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. |