...
...
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: Thank you to all of our presenters and attendees for once again ensuring the Data Transparency Summer event was a great success! Couldn't attend? Not a problem! Click here to visit the PHUSE Engagement Hub where you can catch up on all previous online events.
...
...
The Role of the Statistician and Statistical Programmer in Real-World Data Analysis: The Real World Evidence project, part of the Emerging Trends & Technologies Working Group, hosted the most recent PHUSE Community Forum which took place 6 July. This meeting began with a 30-minute presentation focused on the changes necessary to use real-world data. Its not too late to get involved! Catch up on the recording and join the discussions over on the online Disqus Forum. Chat with like minded individuals on how the changes affects the role of the statistical programmer and the statistician.
Save the date! – 5 October 2022
The Emerging Trends & Technologies Working Group once again presents the next Community Forum: Challenges in Real World Data Ingestion and Standardization.
...
Recently Published Deliverables
...
PHUSE Working Group Co-Lead |
|---|
Are you passionate about data standards and excited by the potential of emerging technologies to optimise their implementation? PHUSE is seeking a motivated and collaborative Co-Lead to help guide the Optimizing the Use of Data Standards Working Group. This is a unique opportunity to shape impactful industry initiatives, work with global experts, and drive innovation in data standards. As a Working Group Co-Lead, you will play a central role in driving the success of multiple projects aligned with advancing the use of data standards. You will collaborate closely with Project Leads, the PHUSE Office, and leadership committees to ensure initiatives are well defined, well supported, and delivered effectively to the broader community. We encourage applications from individuals who:
For more information, visit Optimizing the Use of Data Standards or contact workinggroups@phuse.global. To apply, please send a brief summary of interest and your qualifications to workinggroups@phuse.global by 3 July. |
PHUSE Working Group Project Co-Lead |
|---|
The Optimizing the Use of Data Standards Working Group |
...
Best Practices for the Submission of Data in Japan – 23 June 2022
The PHUSE Japan e-Data Submission team has recently published a White Paper on the electronic submission of data to the PMDA. This White Paper was part of the project's aim in creating materials that will help global personnel submit electronic data to the Pharmaceuticals and Medical Devices Agency (PMDA).
...
Bio-research Monitoring Data Reviewers Guide (BDRG) – 22 June 2022
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.
...
.jpg?version=1&modificationDate=1618921597821&cacheVersion=1&api=v2&width=550)
...
AE Groupings in Safety (AEGiS) – Project Members
The PHUSE Safety Analytics Working Group is launching a new cross-disciplinary project team: AE Groupings in Safety (AEGiS). As noted in the FDA Clinical Review Template (Section 7.1.2 in Attachment B) and the EU SmPC Guideline and emphasised in the 2017 PHUSE adverse events white paper, adverse event categorisation that is too granular can result in underestimation of an event (e.g. somnolence, drowsiness, sedation and sleepiness probably all refer to the same event). This project team will develop points to consider when deciding whether to use a MedDRA-defined grouping of PTs versus creating a custom grouping and will provide recommendations on process/implementation (maintaining custom groupings, analysis planning, ADaM development, tables and figures). Note this project team will not be creating any custom groupings. Final deliverables may include presentations at scientific conferences, publishing a white paper and/or publishing in a peer-reviewed journal.
If you are interested in participating in this project, please email workinggroups@phuse.global.
...
is seeking a Co-Lead to oversee maintenance of the SDSP (Study Data Standardization Plan) package under the Management of ODS Regulatory Referenced Deliverables (MRRD) project. Co-Leads will work under guidance of the MRRD Project Lead and are asked to serve two years in the role. Responsibilities include:
For more information, go to Management of ODS Regulatory Referenced Deliverables or contact workinggroups@phuse.global. To apply, please send a brief summary of interest and your qualifications to workinggroups@phuse.global by 14 July. |
...
Risk Based Quality Management | ||
|---|---|---|
Webinar: Quality Tolerance Limits (QTLs): Setting the Threshold 23 June 10:00-11:00 (EDT) / 15:00-16:00 (BST) / 16:00-17:00 (CEST)
|
Real World Evidence | ||
|---|---|---|
Community Forum: Real World Evidence Meets AI and Privacy 9 July 9:00-10:00 (EDT) / 14:00-15:00 (BST) / 15:00-16:00 (CEST)
|
The Data Transparency Working Group is preparing for its upcoming multi‑day virtual event, taking place 15–17 September 2026 at 10:00–12:30 (EDT) / 15:00–17:30 (BST) / 16:00–18:30 (CEST). The event will focus on the evolving landscape of clinical data transparency, including approaches to data sharing, anonymisation, governance and enabling responsible access to clinical data.
|
Real World Data Autumn Event – Save the Date |
|---|
Join us for the return of the Real World Evidence Working Group’s multi‑day virtual event on 30 September–1 October 2026. The event will run from 09:00–11:30 (EDT), 14:00–16:30 (BST), and 15:00–17:30 (CEST). Registration will open 17 June. |
...
The SEND Industry Feedback Survey project, under the Nonclinical Topics Working Group, is looking for volunteers to support this exciting initiative. This project will help gather valuable industry insights and feedback to support future discussions and improvements within the SEND space. If you are interested in contributing, collaborating with peers, and helping shape this project, we’d love to hear from you. Find out more information about the project on the Volunteer Board. To get involved, please complete the New Member Onboarding Form.
|
If you would like to get involved in a PHUSE Working Group Project, please explore the projects via the Volunteer Board and contact the PHUSE Office on workinggroups@phuse.global to express your interest. |
...
Working Group 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 |
...
...
Working Groups Latest Report Q2 2022: The report includes project updates, recent and upcoming deliverables and the future plans for each Working Group.
...
Monthly Mailings: Our monthly newsletter. Here you will find a full update from each month of the year, easily accessible and divided into key areas of PHUSE.
...
. |