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TransCelerate Event

Webinar: Is Your RWD Regulatory Ready? Considerations When Preparing RWD for a Regulatory Submission

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.

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. 


  • 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.