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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 , USA

Regulatory Submissions, Information, and Document Management Forum

Don't miss the latest trends, innovations, and best practices in regulatory submissions, information, and document management (RSIDM)!

Session 6: Ask the Regulators – Part 2

Session Chair(s)

Jonathan  Resnick, PMP

Jonathan Resnick, PMP

Project Management Officer, OBI, OSP, CDER

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.


Heather  Crandall, MA


Heather Crandall, MA

FDA, United States

Business Informatics Specialist, OBI, OSP, CDER

Suranjan  De, MBA, MS


Suranjan De, MBA, MS

FDA, United States

Deputy Director, Regulatory Science, OSE, CDER

Seyoum  Senay, MS


Seyoum Senay, MS

FDA, United States

Supervisory Operations Research Analyst, CDER/OBI

Norman  Schmuff, PhD


Norman Schmuff, PhD

FDA, United States

Associate Director for Science, OPMA, OPQ

Zhouxi  Wang, PhD


Zhouxi Wang, PhD

FDA, United States

Senior Biologist, OPQ, CDER

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