PhUSE Working Groups Latest News
The PhUSE Working groups which are led by volunteers from major stakeholders have been developing innovative solutions that address unmet computational science needs. Here we will look to share the latest information around the PhUSE working groups, from workshops to white papers, projects news and industry views.
The Industry Experiences Submitting Standardised Study Data to Regulatory Authorities project has launched a 'Discussion Forum' and is seeking your input. The scope of this project is to share submission experiences including, but not limited to submission planning, interactions with the regulators, test submissions, regulator feedback etc. Additionally, this project will explore the development of best practices for biometrics departments to engage with regulators. The project will examine different communication use cases and make recommendations as to ensure effective exchange of information.
If you would like the team to address a question you may have, please post it here.
SDTM FAQ Project has just published their teams response following questions received from the PhUSE Community.
- What are FDA Business and Validator Rules? Team response is published here under the VCR Sub-Team
- ETCD/ELEMENT & EPOCH Variables: Team response is published here under the IGN Sub-Team
If you have a question you'd like to submit to the team, you can do so using this link.
The FDA recently presented at the PhUSE Webinar Wednesday on the Technical Rejection Criteria for Study Data. To view the presentation or listen back to the recording click here.
During EU Connect in Frankfurt Chris Price will be facilitating a working group discussion club. The session will look to bring together industry colleagues and regulatory stakeholders to learn what has been successful in various collaborations, brainstorm the next generation of challenges and innovations to address, and discuss areas to be explored across regulatory agencies to minimise impact on sponsors. Registration for this hands-on work shop will commence in September.
The Pooling WHO Drug B3 Format project have now published their white paper which gives recommendations for pooled submissions with WHODrug B3 format data. To download the final version, visit our deliverables catalog.
Blockchain have just released the final version of their white paper on 'How Blockchain Can Transform the Pharmaceutical and Healthcare Industries'. Click here to view the paper.
The Script Metadata for Sharing project has released a video on the PhUSE Tube to provide information about scripts purpose, version, execution environment, library and data files used, inputs, outputs, review history and ratings. The video aims to make the metadata easier to share, access and execute scripts in the repository. To view the video click here.