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Session 4: New FDA Draft Guidance on Part 11 in Clinical Investigations and Mobile Technologies in Clinical Investigations
Session Chair(s)
Ron Fitzmartin, PhD, MBA
Senior Informatics Advisor, Office of Regulatory Operations, CBER
FDA, United States
This session will review the new 2017 FDA Guidance on 21 CFR Part 11 in Clinical Investigations, the public comments, discuss next steps, and hear from the audience on the topics presented.
Speaker(s)
Part 11 Guidance
Cheryl Grandinetti, PharmD
FDA, United States
Clinical Pharmacologist, OSI, OC, CDER
Regulatory Considerations in the Use of Mobile Technology in Clinical Investigations
Leonard Sacks, MD
FDA, United States
Director, Clinical Methodologies,Office of Medical Policy, CDER