The Community Forum creates a space for the PHUSE Community to unite and discuss industry topics of interest in an informal setting. Alongside this, each Working Group will use Disqus to host offline discussions and continue sharing information. The Community Forum events areThis event is free and taketakes place virtually over Zoom. If you have any questions on Community Forums, contact workinggroups@phuse.global. |
Safety Analytics: Reimagining a Safety Submission – Vision of Interactive Safety Reviews – 27 March 2023
During this Community Forum, you’ll hear about various efforts related to interactive safety reviews. This will then be followed by a discussion on the end goal, potential impact on submissions, and different models for creating and sharing interactive safety review tools. Register here!
Hear from presenters as they dive into what follows after using real-world data for regulatory submissions, and look into examples of mapping and data handling in two ways (OMOP to SDTM and source/SDTM to OMOP). They will explore the challenges of mapping to and from OMOP, which is a more open standard than SDTM and uses a stricter model with strict implementation guides.
To catch up on the previous Community Forums, visit the PHUSE archive. |
Previous Community Forums:
Date/ Time | Working Group | Title | Speakers | Recordings |
---|---|---|---|---|
18 January | Real World Evidence | Dr Cheryl Grandinetti, FDA andKris Wenzel, MMS | Recording | |
21 February | Vera Pomerantseva, ZS Associates | Recording | ||
17 April | Dr. Junshui Ma, Merck | Recording | ||
18 April | Michèle Arnoe, IQVIA, Jeffrey Brown, TriNetX andBenjamin Forred, Sanford Research | Recording |