The Community Forum creates a space for the PHUSE Community to unite and discuss industry topics of interest in an informal setting. Events Events are free and take place virtually over Zoom. Recordings become available shortly after the meeting and each Working Group will use Disqus to to host offline discussions and continue sharing information. Catch up on previous Community Forums below. |
| 2023 Community forums | |||
|---|---|---|---|
| Date | Title | Speakers | Recording |
| 5 October | Real World Evidence: Experiences with Adapting RWD to CDISC Submission Standards | Lauren Green, Amgen, Jeff Abolafia, Pinnacle 21, Christine Rossin & Pfizer, Sandra VanPelt Nguyen, Pfizer. | Recording |
| 6 July | Real World Evidence: Designing Your RWD Study-Is Your Data Fit for Purpose? | Andy Richardson, Zenetar, Elizabeth Merrall, Janssen Research and Development, Jonathan Assayag, Pfizer & Mary Anne Rutkowski, | |
Merck & Co | Recording | ||
| 12 April | Emerging Trends & Technologies: RWD/RWE Programming & Reporting Standards: Utilising OMOP Standards | Berber Snoeijer, ClinLine, Mary Anne Rutkowski, Merck & Co, Jerry Wang, Janssen Research and Development & Mike Briganti, Janssen Research & Development | Recording |
| 27 March | Safety Analytics: |
| Reimagining a Safety Submission – Vision of Interactive Safety Reviews |
TheSafety Analytics Working Group presented on the various efforts related to interactive safety reviews. This was followed by a great discussion on the end goal, potential impact on submissions, and different models for creating and sharing interactive safety review tools. Head over to the Disqus Forum to share your thoughts and ask the presenters your questions!
Greg Ball, ASAPprocess, Mary Nilsson, Eli Lilly, Wei Wang, Eli Lilly, Xiangyun Wang, Genentech, Raj Kiran, Takeda, Melvin Munsaka, Abbvie, Neetu Sangari, Pfizer, Jeremy Wildfire, Gilead, Khushboo Sharma, Accumulus & Bill Gibson, Accumulus | Recording | |
| 21 February |
| Data Transparency: Data Privacy and Data Sharing in Clinical Trials |
Devaki Thavarajah |
, Instem & Deborah Collyar, Founder and President, Patient Advocates in Research (PAIR) | Recording |
| 16 February |
| Safety Analytics: Reimagining a Safety Submission – Aggregate Safety Assessment Planning |
During this Community Forum, presenters introduced two new FDA premarket safety analytics documents and discussed how past and current efforts from cross-industry Working Groups can be leveraged to prepare the ecosystem for operationalising them.
Emerging Trends & Technologies: Submitting Real-world Data – 18 January 2023
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. Catch up now by viewing the recording. Got a question for the presenters? It's not too late to post it on the Disqus forum!
Emerging Trends & Technologies: Ingestion and Standardization of Real-world Data – 5 October 2022
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? Catch up by viewing the recording.
Emerging Trends & Technologies: The Role of the Statistician and Statistical Programmer in Real-World Data Analysis – 6 July 2022
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.
Emerging Trends & Technologies: Enterprise Knowledge Graph supporting Business Improvement – Example with the Clinical Study Process – 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 is available to view here.
The first ever PHUSE Community Forum was hosted by 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.
| Greg Ball, ASAPprocess, Mary Nilsson, Eli Lilly, Mac Gordon, Janssen Research & Development & Barbara Hendrickson, University of Chicago | Recording | ||
| 18 January | Emerging Trends & Technologies: Submitting Real-world Data | Parag Shiralkar, Sumptuous Data Sciences & Jeff Abolafia, Pinnacle 21 | Recording |