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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.

Data Transparency Summer Event 2022

Data Transparency Summer Event: Thank you to all of our presenters and attendees for once again ensuring the Data Transparency Summer event was a great success! Couldn't attend? Not a problem! Click here to visit the PHUSE Engagement Hub where you can catch up on all previous online events. 

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 the Emerging Trends and Technologies Working Group, presents the next PHUSE Community Forum, taking place 6 July, 15:00 (BST)/ 10:00 (EST).

Use of real-world data in regulatory submissions is growing. Real-world data provides unique insights which can be used for informed decision-making, resulting in faster drug approval. However, the nature of real-world data is quite different from that of clinical trial data. While the latter can be controlled at all stages, from collecting to reporting, this is not the case for real-world data. This imposes many challenges including pre-study alignment with regulatory agencies regarding validity of the data used. How does this affect the roles and corresponding responsibilities of various cross-functional clinical team members?

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.

Date: 6 July 2022

Time: 15:00 (BST)/ 10:00 (EST) 

Register here!



                                        

Recently Published Deliverables

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 FAQThe 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 Volunteers

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?

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 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.

June 

Previous 2022 Monthly Mailings 

PHUSE Blogs

PHUSE Diversity & Inclusion Survey

Neurodiversity: Join the Conversation

Can Clinical Data processed with R be Used in a Regulatory Submission?

Pharma Statistical Programming Heads Council  


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