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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 and Call for Posters for the PHUSE/FDA CSS 2024 is now 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.Sponsored by Entimo, the Poster Session will take place on Tuesday 4 June. Seize this opportunity and submit a 150-word abstract by 8 March.Be sure to register by 15 March to use the PHUSE Early Bird discount! 

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Open Forum: Open Source in Pharma and Long-Term Dependability

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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.

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 Calling for FeedbackThe Risk Based Monitoring Working Group has changed to Risk Based Quality Management. With a wider remit focused on RBQM, this Working Group will identify innovative approaches in the planning (Quality by Design, Critical to Quality, Risk Identification and Characterisation), conduct (Risk Control), and continuous improvement (Risk Review, Risk Communication) elements of RBQM that support proactive management data reliability and participant well-being. The leads have produced a survey so you can have your say in the evolution of this Working Group! Please complete this survey by the 


6 March
New Deliverables

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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

has produced a White Paper '

have published a new deliverable. The White Paper is on the topic ofAssessing the Use of Quality Tolerance Limits in the Pharmaceutical Industry

'. By surveying the industry to gather information on the current use of QTLs, this white paper

. This White Paper aims to provide the reader with valuable insights

as to

into the depth and breadth of

their use. It will also address

the use of QTLs and addressing how QTLs are

utilised

used in

the

a wider scope of implementing RBQM

, and the direction of stakeholders given that the regulations regarding the conduct of clinical trials continue to evolve

.

 


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

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Please provide your comments by emailing workinggroups@phuse.global. Closing date for comments: 8 March.

The Risk Based Quality Management Working Group have just initiated a new Project called 'OpenRBQM: Pre-Competitive Collaboration on Open-Source Software for RBQM' which is calling for volunteers! They will form an Open-Source TBQM Working Group and an associated development sub-team. If you are interested in joining, please contact workinggroups@phuse.global by 6 March.

The Optimizing the Use of Data StandardsWorking Group is looking for a new Working Group Lead to join their team. Over the last decade, the development and adoption of data standards have shown significant promise in improving the 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.

The goal of this Working Group is to work together to identify and close those particular gaps that impede industry and the FDA from making the most efficient use of data standards. 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: 29 March.

Volunteer Opportunities

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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 

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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. 

BIMO FAQ Forum Global Survey

Do you have a question relating to Bioresearch Monitoring (BIMO)? The PHUSE Bioresearch Monitoring (BIMO) Frequently Asked Questions Forum Project Team are here to help. You can find all previous BIMO questions and answers published here. 

Instructions for submitting your questions via the BIMO FAQ Survey:

Download the file named PHUSE BIMO FAQ Forum Project _Global Survey for collecting your questions.xlsx to add your questions to the BIMO FAQ Survey.
  • Complete the file with your questions as per the instructions in the ‘Survey Instructions’ tab.
  • Save and submit to the PHUSE BIMO FAQ Forum Project Team via email at workinggroups@phuse.global by 31 March 2024.

    • We look forward to receiving your BIMO questions!

    SDTM ADaM Questions

    The SDTM ADaM Implementation FAQ project within Optimizing the Use of Data Standards wants 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 on the project page, under Objectives & Deliverables.


    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? 

    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: 

    • The projects must address significant research issues relevant to Computational Science
    • The project must not attempt to address FDA policy issues
    • There must be at least one Project Lead personally involved in planning and carrying out the project

    New projects can be submitted anytime during the year, click here to submit. 

    PHUSE Communications 

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    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.

    .