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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 for the PHUSE/FDA CSS 2024 is now open! Make sure to register by the 15th of March to secure an early bird ticket. Ready to register? REGISTER HEREto secure your spot.

Are you interested in presenting a poster? The Call for Posters is officially open too!  Submit your poster proposal by March 8th. Check out the submission guidelines and registration REGISTER HERE

Data Transparency Winter Event 2024

The PHUSE Data Transparency Winter Event will take place from 6–8 February 2024. The Data Transparency Event offers you the chance to gain knowledge and experience from a wide data transparency community, allowing you to come together with expects from a variety of companies and backgrounds.

During this virtual event, presentations will be delivered across the three days in bitesize chunks from 15:00-17:30 (GMT). There will also be a panel discussion and Q&A session focused on the day's themes. To view the agenda and full event information, visit the event page.

REGISTER HERE

Optimizing the Use of Data Standards: Dataset-JSON as Alternative Transport Format for Regulatory Submissions Webinar 

The Dataset-JSON as Alternative Transport Format for Regulatory Submissions project, part of the Optimizing the Use of Data Standards group is hosting a webinar on 1 February 15:00-16:00 (GMT) 10:00-11:00 (EDT) to give a mid project status and update on the progress across the four work-streams, there will also be an interactive Q&A session to give you an opportunity to raise any questions and provide feedback.

REGISTER HERE

Risk Based Quality Management - The Risk Based Management Feedback Loop Community Forum

The Centralised Monitoring Capabilities project within the Risk Based Quality Management Working Group Is hosting a Community Forum on the The Risk Based Monitoring Feedback Loop. This will be an interactive session with Vera Pomerantseva who is Associate Partner, Risk and Quality Management Lead at ZS Associates. The forum will discuss the journey of the risk signal communication and the experiences and challenges that occur in the process. This Community Forum will take place over Zoom on 21 February 15:00 -16:00 GMT / 10:00 -11:00 EST. 

REGISTER HERE

Deliverables Calling for Feedback

The Adverse Event Collection Recommendations project within the Safety Analytics Working Group has produced a White Paper 'Adverse Event Collection Recommendations'. which provides recommendations for Adverse Event Collection Instructions, with a focus on Phase 2-4 clinical trials. The team are calling for your feedback!

Please provide your comments by emailing workinggroups@phuse.global. Closing date for comments: 14 February.

Volunteer Opportunities

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 Packor 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. 

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