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Session 1 Track 3: eTMF & eSignatures: Issued, Applied, Inspected
Session Chair(s)
Lisa Mulcahy
Owner, Principal Consultant
Mulcahy Consulting, LLC, United States
As healthcare moves away from paper to a broader adoption of digitized documents, a key component to enabling that adoption is a digital signature. A case study will be presented from the digital credential provider and the medical practice that underwent an assessment, selection and adoption of the technology. The attendee will learn how the Sarah Canon Research Institute identified the business needs, completed the supplier evaluations, and choose the appropriate vendor for their needs. To complement the adoption of the digital credential, a former inspector will share his GCP experience with TMF and electronic documents while at the FDA and recent opportunities advising Sponsors and CROs.
Learning Objective : Gain Regulator perspective on the topic of electronic TMF management Gain Regulator perspective on key points about inspection of the TMF using an eTMF system
Speaker(s)
Speaker
Mike M Rashti, RPh
BIMO Auditor & Trainer, LLC, United States
Consultant
Speaker
Peyton Hale
Sarah Cannon Research Institute, United States
Speaker
John B. Harris
SIGNiX, United States
Senior Vice President of Product Management
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