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. |
Data Transparency Summer Event 2022 | |
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Data Transparency Summer Event: Last chance to register! Taking place 28-30 June, this virtual and free event is not one to be missed. Click here to view the full agenda and to register. | |
CSS 2022 | |
CSS: This year's PHUSE/ FDA CSS takes place 19-21 September. To find out more, take a look at the agenda on the PHUSE website. For this event, the reduced Early Bird rate ends 1 July. Don't miss out, Click here to register! |
Community Forum | ||
The Role of the Statistician and Statistical Programmer in Real-World Data Analysis:The Real World Evidence project, part of theEmerging Trends and Technologies Working Group, presents the next PHUSE Community Forum, taking place 6 July, 15:00 (BST)/ 10:00 (EST). This meeting will start with a 30-minute presentation focused on the changes necessary to use real-world data followed by a forum discussion on how this affects the role of the statistical programmer and the statistician.
If you are interested in attending this event, register here! |
Recently Published Deliverables |
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If you wish to view the extensive list of all PHUSE published deliverables, click here. |
Bio-research Monitoring Data Reviewers Guide (BDRG) – The Optimizing the Use of Data Standards Working Group and the PHUSE BIMO Project Team are pleased to announce the publication of the Bio-research Monitoring Data Reviewer’s Guide (BDRG) Package. This reviewer’s guide was created to provide the industry with a consistent way and usable format for communicating information concerning the Bio-research Monitoring (BIMO) data to regulatory agency reviewers. The BDRG package includes an Introduction and Overview, Template, Completion Guidelines and three Examples. |
Best Practices for the Submission of Data in Japan – The PHUSE Japan e-Data Submission team has recently published a White Paper on the electronic submission of data to the PMDA. This White Paper was part of the project's aim in creating materials that will help global personnel submit electronic data to the Pharmaceuticals and Medical Devices Agency (PMDA). |
Recommendations for SEND Dataset QC Best Practices – The SEND Dataset QC Best Practices project within the Nonclinical Topics Working Group have been busy working on a new deliverable which has recently been published. The White Paper provides key insights into current QC activities performed by industry as well as best practice recommendations for QC procedures. The aim is to promote more consistent QC procedures to help regulatory reviewers be more confident the SEND data accurately represents the data in the study report. |
SDTM ADaM Implementation FAQ- The SDTM ADaM Implementation FAQ project, under the Optimizing the Use of Data Standards Working Group, has published a new response to a question they received under Validation/Conformance Rules. The question is based on whether an SDTM domain that is in the SDTM IG v3.3 be used for a study that is using the SDTM IG v3.2 to map the study data. |
Projects Calling for Members |
For more information on the PHUSE Working Groups and their projects, click here. If you would like to become a valued member of PHUSE and volunteer for one or multiple projects, please email: workinggroups@phuse.global. |
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 to submit. |
PHUSE Communications | |
Working Groups Latest Report: Q12022 | This Report provides a detailed overview of the projects progress this past quarter. |
Monthly Mailings: Our 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 | PHUSE Diversity & Inclusion Survey Neurodiversity: Join the Conversation Can Clinical Data processed with R be Used in a Regulatory Submission? |