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Bethesda North Marriott Hotel and Conference Center

05 feb 2018 7:00 a.m. - 07 feb 2018 3:00 p.m.

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Regulatory Submissions, Information, and Document Management Forum

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Session 4: New FDA Draft Guidance on Part 11 in Clinical Investigations and Mobile Technologies in Clinical Investigations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 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

Associate Director for Clinical Policy, CDER/OC/OSI/DCCE

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

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Regulatory Submissions, Information, and Document Management Forum

Session 4: New FDA Draft Guidance on Part 11 in Clinical Investigations and Mobile Technologies in Clinical Investigations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

Speaker(s)

Part 11 Guidance

Regulatory Considerations in the Use of Mobile Technology in Clinical Investigations

Be informed and stay engaged.