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Session 3: FDA - Ask the Regulators
Session Chair(s)
Jonathan Resnick, PMP
Advisor, Office of Digital Transformation, FDA, United States
Seyoum Senay, MS
Supervisory Operations Research Analyst, CDER/OBI, 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. Note: Please hold all questions on eCTD v4.0 until Session 4.
- ESG: Jessica Bernhardt, FDA
- Updates to eCTD for v3.2.2 and v4.0: Heather Crandall, FDA
- CDER NextGen Portal: Seyoum Senay, FDA
- FDA’S Global Substance Registration System (GSRS) of Structure Data (SD) File to have Unique Ingredient Identifiers (UNIIs) for FDA-regulated Products: Siba Bhattacharyya, FDA
- Jonathan Resnick, FDA
Speaker(s)
ESG
Jessica Bernhardt, MS
IT Project Manager ODT, FDA, United States
Updates to eCTD for v3.2.2 and v4.0
Heather Crandall, MA
Business Informatics Specialist, OBI, FDA, FDA, United States
CDER NextGen Portal
Seyoum Senay, MS
Supervisory Operations Research Analyst, CDER/OBI, FDA, United States
Global Substance Registration System (GSRS) and submitting Structure Data File (SDF) to FDA
Siba P Bhattacharyya, PhD
Health Scientist, OC/ODT/ODAR/HIS, FDA, United States
Speaker
Jonathan Resnick, PMP
Advisor, Office of Digital Transformation, FDA, United States
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