| 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 |
|---|
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. |
| Open Forum: Open Source in Pharma and Long-Term Dependability |
|---|
|
The Open Source Technology in Clinical Data Analytics (OSTCDA) project is hosting an Open Forum on the topic of Open Source in Pharma and Long-Term Dependability with speaker Mike Smith. This forum will be taking place on zoom on 17 May 15:00-16:00 BST / 10:00-11:00 EDT. |
| 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 Standards Working 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 Rules page. You can see all the FAQ this project has answered so far via here. Do you have a SDTM ADaM question? You can send your questions to the team by emailing workinggroups@phuse.global |
. The Quality Tolerance Limits project within the Risk Based Quality Management Working Group |
have published a new deliverable. The White Paper is on the topic ofAssessing the Use of Quality Tolerance Limits in the Pharmaceutical Industry |
. This White Paper aims to provide the reader with valuable insights |
into the depth and breadth of |
the use of QTLs and addressing how QTLs are |
used in |
a wider scope of implementing RBQM |
. |
Calling for Feedback |
|---|
| The Treatment Emergent Definitions Recommendations project within Safety Analytics Working Group has produced a White Paper 'Recommended Definition of Treatment-Emergent Adverse Events in Clinical Trials'.This document defines treatment-emergent events in Phase 1 to 4 clinical trials and integrated summary documents across therapeutic areas. The recommendations described herein were based on the authors’ collective experiences and a survey conducted by the PHUSE Treatment-Emergent Definition Recommendations project team [2] to solicit input from respondents on various TEAE scenarios for a simple clinical study design. Please provide your comments by emailing workinggroups@phuse.global. Closing date for comments: |
7 June |
Volunteer Opportunities |
|---|
|
We’re looking for a Working Group Lead for our Optimizing the Use of Data Standards Working Group, which aims to support, address and answer pertinent questions within the industry.
Working Group Scope
The development and adoption of data standards over the last decade has shown significant promise in improving 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. This Working Group will collaborate to close those specific gaps that prevent the FDA and industry from optimising the use of data standards. You can view the current projects within this Work Group via here.
Roles and Responsibilities
You can learn about aWorking Group Lead's Roles and Responsibilities here.If you are interested in this role or have any questions, please contact: workinggroups@phuse.global. Closing date: 29 March.
The SDTM ADaM Implementation FAQ project within Optimizing the Use of Data Standards are wanting 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 the project page, under Objectives & Deliverables.
TheEstimands for RWD/RWE a new project within Real World Evidence Working Group is now calling for volunteers. The focus of this project is on best practices of RWD estimands, not on their implementation using data standards. The team formed would have representation from the PHUSE Implementation of Estimands (ICH E9 (R1)) using Data Standards project team, which has a white paper nearing publication as of 2024Q1, and the Estimands Implementation Working Group (EIWG) sub team on HTA and RWE, both with estimands expertise, along with representation from teams under the RWE Working Group. If you would like to volunteer or learn more about this project, email workinggroups@phuse.global. Closing date: 7 June |
Volunteer Opportunities
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. | |
| New Project Idea? | |
|---|---|
| Announcement |
|---|
PHUSE Communications | |
Working Groups Report: Includes project updates, recent and upcoming deliverables and the 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 the 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? |
|---|
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. |