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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.

Early Bird Registration

The PHUSE/FDA Computational Science Symposium will return for its 12th year from 18–20 September in Sliver Spring, MD. Register by 30 June to benefit from the PHUSE Early Bird discount.

New Working Group: Real World Evidence

PHUSE are extremely proud to welcome the eighth PHUSE Working Group; Real World Evidence. The importance of this industry area has become increasingly apparent over recent years and the launch of this Working Group honours that. Working Group leads, Berber Snoeijer and David Hood, are looking forward to kicking off with exciting projects on real-world data sources, code and analysis techniques, and submission requirements. 

To volunteer for one or more projects within the new Real World Evidence Working Group, email workinggroups@phuse.global. 

Safety Analytics Webinar Series: Interdisciplinary Safety Evaluation for Learning and Decision-Making

The Safety Analytics Working Group will be delivering a series of virtual, free to attend webinars over the coming months. The second webinar will be on Overall Safety Assessment – Standard Safety Tables and Figures, taking place on 13 July 15:00-16:30 (BST). Click here to register!

Designing your RWD Study: Is Your Data Fit For Purpose?

The Real World Evidence Working Group will be hosting a Community Forum on Designing your RWD Study: Is Your Data Fit For Purpose? This Community Forum will take place on 6 July, 14:00–15:00(BST)/09:00–10:00 (EST). Click here to register! 


Volunteer Opportunities

Nonclinical Topics’ new project Nonclinical Protocol Automation is now calling for volunteers. 

This project plans to Determine the feasibility of transforming the BioCelerate Nonclinical Protocol Template into a dynamic Microsoft Word document where filling in the template allows output of all fields for machine readability. Determine the feasibility of expanding the OpenStudyBuilder system for nonclinical study usage. Explore the output and API functionality of this system. Based upon conclusions from the above, work with one or both groups to complete a pilot for creating a few model study designs for demonstration of protocol automation.

Please contact workinggroups@PHUSE.com to register your interest in volunteering.

Call for Working Group Leads 

The Risk Based Monitoring Working Group are actively seeking two new Working Group Leads, click here for further information. 

All applications are to be submitted to our Working Groups Director, Chris Price, at chris.price@phuse.global. Closing date for applications is 21 July.

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. 

Deliverables For Review 

The Centralised Monitoring Capabilities Project has produced a White Paper focusing on the value of CM as it relates to the protection of data integrity and quality. This paper also explores the subsequent considerations and challenges in demonstrating this value and has leveraged the industry survey conducted by the Project – exploring case studies and review of industry literature. The team are calling for feedback on the White Paper, please provide any comments to workinggroups@phuse.global by 28 July. 

Recently Published Deliverables 
The Bio-research Monitoring Data Reviewers Guide project has updated their Data Reviewer’s Guide Template (BDRG). Version 3.0 of the BDRG provides regulatory agency reviewers an orientation to the submitted Bioresearch Monitoring (BIMO) data in a consistent way and usable format. The BDRG Package includes an Introduction and Overview, Template, Completion Guidelines and Examples. 
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, 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 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 bought to you by industry professionals. 

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