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Session 4: New FDA Draft Guidance on Part 11 in Clinical Investigations and Mobile Technologies in Clinical Investigations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, MBA
Principal Consultant, Decision Analytics, 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)
Cheryl Grandinetti
Associate Director for Clinical Policy, CDER/OC/OSI/DCCE, FDA, United States
Part 11 Guidance
Leonard Sacks, MD
Director, Clinical Methodologies,Office of Medical Policy, CDER, FDA, United States
Regulatory Considerations in the Use of Mobile Technology in Clinical Investigations