| 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. |
Data Transparency Summer Event 2022
Data Transparency Summer Event: Last chance to register! Taking place 28-30 June, this virtual and free event is not one to be missed. Click here to view the full agenda and to register.
CSS 2022
CSS: This year's PHUSE/ FDA CSS takes place 19-21 September. To find out more, take a look at the agenda on the PHUSE website. For this event, the reduced Early Bird rate ends 1 July. Don't miss out, Click here to register!
The Role of the Statistician and Statistical Programmer in Real-World Data Analysis:
The Real World Evidence project, part of the Emerging Trends and Technologies Working Group,
presents the next PHUSE Community Forum, taking place 6 July, 15:00 (BST)/ 10:00 (EST).
This meeting will start with a 30-minute presentation focused on the changes necessary
to use real-world data followed by a forum discussion on how this affects
the role of the statistical programmer and the statistician.
Date: 6 July
Time: 15:00 (BST)/ 10:00 (EST)
Register Here
|
| PHUSE/FDA CSS 2024 | ||||||
|---|---|---|---|---|---|---|
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.
|
| Calling For Feedback |
|---|
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. |
Recently Published Deliverables
Bio-research Monitoring Data Reviewers Guide (BDRG) – The Optimizing the Use of Data Standards Working Group and the PHUSE BIMO Project Team are pleased to announce the publication of the Bio-research Monitoring Data Reviewer’s Guide (BDRG) Package. This reviewer’s guide was created to provide the industry with a consistent way and usable format for communicating information concerning the Bio-research Monitoring (BIMO) data to regulatory agency reviewers. The BDRG package includes an Introduction and Overview, Template, Completion Guidelines and three Examples.
Recommendations for SEND Dataset QC Best Practices – The SEND Dataset QC Best Practices project within the Nonclinical Topics Working Group have been busy working on a new deliverable which has recently been published. The White Paper provides key insights into current QC activities performed by industry as well as best practice recommendations for QC procedures. The aim is to promote more consistent QC procedures to help regulatory reviewers be more confident the SEND data accurately represents the data in the study report.
| New Deliverables |
|---|
|
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 StandardsWorking 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 Rulespage. |
You can see all the FAQ this project has answered so far viahere. Do you have a SDTM ADaM question? You can send your questions to the team by emailing workinggroups@phuse.global. |
Volunteer Opportunities | |
|---|---|
| |
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? |
|---|
For more information on the PHUSE Working Groups and their projects, click here. If you would like to become a valued member of PHUSE and volunteer for one or multiple projects, please email: workinggroups@phuse.global.
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. |
Working Groups Latest Report: Q12022
PHUSE Blogs
PHUSE Diversity & Inclusion Survey
Neurodiversity: Join the ConversationCan Clinical Data processed with R be Used in a Regulatory Submission?
Pharma Statistical Programming Heads Council
|