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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.

PHUSE/FDA Innovation Challenge 

Following the success of the first Challenge, PHUSE is excited to launch the 2022 PHUSE/FDA Innovation Challenge.

Participant teams will present their solutions at the US Connect 2022 in Atlanta, GA. This event will be one of the highlights of the year with unparalleled learning opportunities and exposure to cutting edge problem-solving along the selected Challenge themes. You can help shape the challenge, by submitting to the challenge themes.

CLICK HERE

Projects Calling for Participants 

Email workinggroups@phuse.global to get involved

R Environment System Qualification – Project Members

The 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. 

Good Transparency Practices – Project Co-Lead and Members

The project aims to define a set of best practices for data transparency and create a Good Transparency Practices guidance. The best practices will help ensure anonymised data is compliant with the legal requirements, as defined by regulators, as well as preserving as much data utility as possible. 

Educate the General Population on Data Privacy and Data Sharing – Project Members

This 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. 

Digital Biomarkers In Clinical Submissions – Project Co-Lead And Members

This 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.

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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