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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, email: workinggroups@phuse.global.

 



Working Groups Latest Report: Q22021This Report provides a detailed overview of the projects progress this past quarter.
Working Groups Events 

30th July 2021 at 15.00 (BST) 

Technical Conformance Guide & Test Data Submission to the eData FDA team

During the live event we will address questions from the industry on, the Study Data Technical Conformance Guide (TCG), the Technical Rejection Criteria (TRC) and submitting test data to the FDA. 

Please join our panel of PHUSE-appointed Subject Matter Experts (SMEs) from industry and the FDA, who will discuss their own experiences of submitting study data to the FDA eData (CBER and CDER) team and take questions from the audience.

As a pre-read to this event, please reference the TCG and TRC guidance. For information on submitting an eCTD or Standardised Data Sample to the FDA, please reference link. For further information on the Study Data Submission to CDER and CBER, click here.

Attendees are encouraged to submit their question in advance via this form, or at the event through the virtual event portal.

REGISTER NOW

11th August 2021 at 15.00 (BST) 

PHUSE/FDA Innovation Challenge Roadmap

We are excited to announce the PHUSE/FDA Innovation Challenge for 2022!

This will be a key highlight of the year with unparalleled learning opportunities and exposure to cutting edge problem-solving along the selected themes. Solutions will be presented during the US Connect 2022 in Atlanta, GA, 13–16 February.

Join this webinar to find out more and to hear the Innovation Challenge’s roadmap and the journey it will take from concept to challenges to solutions through our PHUSE/FDA CSS in September 2021 and the US Connect 2022.

This is also your exclusive opportunity to help shape the Innovation Challenge and submit challenge themes that can be solved through the work of the Challenge participants

REGISTER NOW

6th August 2021 at 15.00 (BST) 

Testing Simplified TS Examples Against FDA Technical Rejection Criteria for Nonclinical Studies

The Nonclinical Topics Working Group created a project to enable the industry to confidently know what TS files will be accepted and avoid a rejection. The results of this project will be described in this meeting.
The project results are important because:

1. No one wants to be responsible for a rejection.
2. Only sponsor organisations will receive warning messages between now and Q4, AND only if they have a submission between now and then.
3. Not all organisations involved in creating submission components will have the opportunity to create a test submission before the rejection criteria go into effect.
4. An organised test reduced the burden on the FDA compared to each organisation submitting test submissions.

This meeting will cover the test cases used, showing which passed and which failed. The test cases were assembled into one eCTD and submitted to the FDA test submission gateway. The eCTD was prepared as if it were a Commercial IND for CDER.

REGISTER NOW

Projects Calling for Participants 

Email workinggroups@phuse.global to get involved

A new project under the Data Visualisation & Open Source Technology Working Group is calling for volunteers. The R Environment System Qualification project is looking to develop scripts to qualify an R environment, including the base installation and additional R framework exists for the base installation tests. This project will collaborate with the RValidationHub and the RConsortium to gather requirements for R environments and best practices for qualifying R systems. The Digital Biomarkers in Clinical Submissions project identifies current state of digital biomarkers in clinical sector and its future impact. It will cover the topics: Classification of existing digital biomarkers, Clinical Therapeutic areas where digital biomarkers usage is progressing, limitations, etc., Stakeholders impacted are Pharma, CROs, tech companies, regulators and SDOs. “DB360” will be built on the paper DH08 submitted in PHUSE US Connect 2020 with final outcome of White Paper and presentations at PHUSE conferences in 2022. 
The Educate the General Population on Data Privacy and Data Sharing project is looking to produce engaging content on data privacy and data sharing that can be understood and used by the general population covering topics such as what is being done to share clinical trial data and information, where data goes and how it is used, what data privacy is, why it is needed, why it is important and the differences between mandatory vs. voluntary data sharing. 
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, biologic 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 for template and submission.

Webinars Events 

Have you attended a PHUSE Webinar Wednesday?

They run throughout the year around the last Wednesday of every month and include presentations of hot topics in the industry and PHUSE.

Click here to register and view previous presentations. 

Our PHUSE events are different in both nature and set-up. PHUSE events started back in 2004 with the inaugural PHUSE conference in Heidelberg. Since then, PHUSE has been organising events all over the globe. With that, we strive to meet the needs of our global community to share, advance and connect. All our events are aimed at different audiences. Click the banner above to see upcoming events. 


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