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Is Your RWD Regulatory Ready? Considerations When Preparing RWD for a Regulatory Submission
Event Date: Thursday, 6 June 2024
Event Time: 10:00 to 11:00 a.m. EST
Join us for a presentation and panel Q&A to learn how the TransCelerate Audit Readiness Initiative has developed a set of considerations to support audit and inspection readiness for programs incorporating real-world evidence (RWE) and focusing on processes used to document data reliability. These considerations can help streamline the application of GCP-like principles to submission using RWE for regulatory decision-making. The considerations operationalize recently developed regulatory frameworks on the fit-for-purpose use of RWE and the documentation needed to give Health Authorities confidence in using RWD for regulatory decision-making.
During the webinar, we will share key elements of TransCelerate’s considerations and summary results of a survey to providers of data services that explored the current landscape.
Panelists:
- Gracy Crane, International Regulatory Policy Lead (RWD & Data Policy), Roche
- Nicole Mahoney, Executive Director, US Regulatory Policy and Intelligence, Novartis
- Abi Seifert, Global Head Country Development Quality, Novartis
- Allison Cuff Shimooka, Chief Operating Officer, TransCelerate
Ideal Attendees:
- Regulatory
- Quality Assurance
- Statistics
- Pharmacovigilance
- Epidemiologists
- Data Scientists
- Clinical Trial teams
- Evidence Generation teams
- RWD/RWE Groups or Users
- Providers of Data Services
TransCelerate webinars may be recorded in whole or in part.