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Bethesda North Marriott Hotel and Conference Center

Feb 12, 2024 8:00 AM - Feb 14, 2024 2:30 PM

5701 Marinelli Road, North Bethesda, MD 20852

Regulatory Submissions, Information, and Document Management Forum

Session 6: Ask the Regulators – Part 2

Session Chair(s)

Jonathan  Resnick, PMP

Jonathan Resnick, PMP

Advisor, Office of Digital Transformation, 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. We encourage participants to consider the regulators' backgrounds and expertise when directing their questions to ensure a more tailored and focused discussion.

Speaker(s)

Heather  Crandall, MA

Speaker

Heather Crandall, MA

Business Informatics Specialist, OBI, FDA, FDA, United States

Suranjan  De, MBA, MS

Speaker

Suranjan De, MBA, MS

Deputy Director, Regulatory Science, OSE, CDER, FDA, United States

Seyoum  Senay, MS

Speaker

Seyoum Senay, MS

Supervisory Operations Research Analyst, CDER/OBI, FDA, United States

Norman  Schmuff, PhD

Speaker

Norman Schmuff, PhD

, Retired, United States

Zhouxi  Wang, PhD

Speaker

Zhouxi Wang, PhD

Senior Biologist, OPQ, CDER, FDA, United States

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