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Bethesda North Marriott Hotel and Conference Center

2023 年 02 月 13 日 11:30 上午 - 2023 年 02 月 15 日 2:15 下午

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

Regulatory Submissions, Information, and Document Management Forum

Session 3: FDA: Ask the Regulators

Session Chair(s)

Ron  Fitzmartin, PhD, MBA

Ron Fitzmartin, PhD, MBA

Senior Advisor, Office of Regulatory Operations, CBER

FDA, United States

Dedicated to sharing the latest information on new guidance’s, this session will allow open discussion between the audience and an esteemed panel of regulatory experts. This session provides attendees the opportunity to ask regulators questions directly.

Please note: due to the high volume of questions, not all will be answered live at the forum

Speaker(s)

Mary Ann  Slack

Speaker

Mary Ann Slack

FDA, United States

Director, Office of Strategic Programs, CDER

Andrew  Potter, PhD

Speaker

Andrew Potter, PhD

FDA, United States

Mathematical Statistician, OB, OTS, CDER

Ta-Jen  Chen, MS

Speaker

Ta-Jen Chen, MS

FDA, United States

Project Management Officer, OSP, CDER

Christopher  Joneckis, PhD

Speaker

Christopher Joneckis, PhD

FDA, United States

Associate Director for Review Management, CBER

Ray  Wang, MBA, MS

Speaker

Ray Wang, MBA, MS

FDA, United States

Director, Data Standards Staff, OSP, CDER

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