You are viewing an old version of this page. View the current version.

Compare with Current View Page History

« Previous Version 957 Next »

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!

REGISTER HERE

 Calling for Feedback

The SEND Industry Feedback Survey Project, within the Nonclinical Topics Working Group have published their 2024 survey! The survey will be live until 23 February with questions on the topics of manual edits, progress on new implementation guides and harmonisation of current SEND initiatives. This is an anonymous survey and the information gathered will be shared at the upcoming PHUSE/FDA CSS 2024.

The 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.


The Quality Tolerance Limits project within Risk Based Quality Management Working Group has produced a White Paper 'Assessing 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 aims to provide the reader with valuable insights as to the depth and breadth of their use. It will also address how QTLs are utilised in the wider scope of implementing RBQM, and the direction of stakeholders given that the regulations regarding the conduct of clinical trials continue to evolve.  

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

SDTM ADaM Questions

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, China FDA). 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.

Volunteer Opportunities

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.

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? 

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 

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 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. 

  • No labels