Watch this webinar 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.
During the webinar, panelists shared key elements of TransCelerate’s considerations and summary results of a survey to providers of data services that explored the current landscape.
Slides can be viewed here. Watch the webinar here.
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