PHUSE Community Forum

Safety Analytics: Reimagining a Safety Submission – Aggregate Safety Assessment Planning

The Safety Analytics Working Group will present their first ever Community Forum on 16 February 2023! 

Hear from PHUSE Safety Analytics Working Group Leads, Mary Nilsson and Greg Ball, as well as Barbara Hendrickson and Robert Gordon, as they introduce two new FDA premarket safety analytics documents. A discussion will then take place on how past and current efforts from cross-industry Working Groups can be leveraged to prepare the ecosystem for operationalising them. Register here! 

Emerging Trends & Technologies: Submitting Real World Data. 

Presenters Parag Shiralkar (Sumptuous Data Sciences) and Jeff Abolafia (Pinnacle 21) will discuss the approach to planning the submission of RWD to regulatory bodies. As part of the planning, interpretation and use of regulatory guidance, this Community Forum will investigate issues, gaps and challenges, as well as possible resolutions and recommendations, for submitting RWD.

Informative presentations will be alternated with Q&A sessions, followed by an online Disqus forum to continue the conversation on this subject and exchange experiences and ideas post event.

Submitting Real-world Data takes place over Zoom on 18 January 2023. Click here to register! 

Emerging Trends & Technologies: Ingestion and Standardization of Real World Data.

The latest PHUSE Community Forum took place 5 October 2022 and was yet again a great success! This Community Forum discussed the options and challenges when using and standardizing a variety of available real-world data sources including the corresponding data models and ingestion methods. Questions and discussions took place after each topic as well as a general Q&A at the end.

Couldn't attend? Ensure you don't miss out! Catch up by viewing the recording. 

Emerging Trends & Technologies: The Role of the Statistician and Statistical Programmer in Real-World Data Analysis 

Real World Evidence hosted the Community Forum, The Role of the Statistician and Statistical Programmer in Real-World Data Analysis, which took place place 6 July 2022. This event started 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. Catch up here! 

Data Visualisation & Open Source Technology: Pharma Focused Initiatives within the R Consortium 

The Pharma Focused Initiatives within the R Consortium Community Forum took place 7 December 2021. In this Community Forum which falls under the Data Visualisation & Open Source Technology Working Group, Joseph Rickert of RStudio discussed ongoing initiatives within the R Consortium focused on the use of R in pharma.

Emerging Trends & Technologies: Enterprise Knowledge Graph supporting Business Improvement – Example with the Clinical Study Process

The Emerging Trends & Technologies Community Forum occurred 29 June 2021. Enterprise Knowledge Graph supporting Business Improvement – Example with the Clinical Study Process featured ex-employee at Novartis, Cedric Berger, as the presenter. Cedric lead the discussion with his experiences on how an enterprise knowledge graph enables to reconsider and significantly improve the process of designing, implementing, conducting a clinical study as well as cleaning, analysing and publishing collected data. The recording of this event is available to view here.