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: Q22021 | This 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. |
Projects Calling for Participants Email workinggroups@phuse.global to get involved | |
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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. | 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. |
The Treatment Emergence Definition Recommendations project is seeking your input on the treatment emergent (TE) definition for various patient event scenarios for a basic, two-period, two-treatment study design. Please utilise this link to access the survey, it should take approximately 5 to 10 minutes to complete. Based on your responses, the project team will develop a set of recommendations and best practices regarding how TE should be defined for this design. Results will be shared in a future PHUSE deliverable. Further recommendations and best practices may be developed for more complex designs in the future. This survey will close September 24th, your input will help us to better harmonise industry practices. |
Project Idea? |
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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:
New projects can be submitted anytime during the year, click here for template and submission. |
Webinars | Events |
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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. | 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. |