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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

The PHUSE/FDA Computational Science Symposium will return for its 12th year from 18–20 September in Sliver Spring, MD. Click here to see an overview of the agenda and Working Group breakout sessions. 

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 third webinar will take place on 14 September on the topic of 'Safety Analytics Webinar Series: Overall Safety Assessment – AE Groupings for Assessment of Safety Topics of Interest'. Click here to register, a list of all upcoming webinars and previous webinars can be found here.

Real World Evidence Community Forum: Experiences with Adapting RWD into CDISC Submission Standards

Save the date! The Real World Evidence Working Group will be hosting another Community Forum, 5 October 14:00–15:00 (BST) 09:00–10:00 (EDT). Presentations will be on the topic of 'Experiences with Adapting RWD into CDISC Submission Standards'. Registration will open soon. 

Announcements

Please welcome the two new leads for the Risk Based Monitoring Working Group, Jeremy Howells (Roche) and Michael Walega (BMS). They will be taking over from Marion Wolfs and Andy Lawton, we'd like to take this opportunity to thank Marion and Andy for the work they have put into PHUSE and the Risk Based Monitoring Working Group.


Volunteer Opportunities

Real World Evidence Working Group’s new project, Real World Data Guideline/White Paper for Statistical Programmers is now calling for volunteers. The aim of this project is for statistical programmers across pharma to collaborate and provide their input to create an RWE Guideline/White Paper for the industry. 

Data Transparency Working Group's new project Anonymization of Imaging Data is now calling for volunteers. This project plans to complete a literature review on types of imaging files including (X-rays, (f)MRIs, CT scans, etc.), their formats (DICOM, NIfTI, etc.), their positions (limbs, heads, organs, etc.) and all associated metadata. There will also be a discussion on data handling, storage and transfer. Any existing guidance and repositories will be reviewed. We will then focus on use cases that will have the most impact based on interest and complexity. 

Real World Evidence Working Group's project Real World Evidence Guidance have compiled a collection of frequently asked questions about using Real World Evidence. Check out the Real World Evidence Guidance Q&A page to see some of the teams' responses and the schedule of upcoming questions.

Please contact workinggroups@phuse.global to register your interest in volunteering.

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 Cloud Adoption in the Life Sciences Industry project has made an update to their Cloud Framework, Pre-Amble White Paper. Since the original publication of this framework, adoption of the public cloud by Life Sciences has become necessary, and no longer the exception. As part of this foreseeable evolution, there has been a significant rise in the construction of hybrid and/or multi-cloud systems. This framework outlines these approaches leveraging well recognised concepts. The team are calling for feedback on the White Paper, please provide any comments to workinggroups@phuse.global by 23 August

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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