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Session 3: FDA Plenary: Data and Technology Strategy
Session Chair(s)
Seyoum Senay, MS
Supervisory Operations Research Analyst, CDER/OBI
FDA, United States
This session provides an overview of ongoing initiatives and updates within the FDA. Key discussions focused on the CDER and CBER Modernization Strategy. The FDA Electronic Submissions Gateway (ESG) NextGen, showcasing submission processing efficiency. Additionally, insights into the ICH Pharmaceutical Quality Knowledge Management (PQKM) technology task force update and Information Request (IR) Proof of Concept. Overall, the session will underscore the FDA’s commitment to advancing regulatory science.
Learning Objective : - Identify key components of the CDER Informatics Platform Modernization
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Summarize the latest CBER Modernization initiatives
- Explain improvements introduced by the FDA’s Electronic Submissions Gateway (ESG) NextGen
- Demonstrate knowledge from the ICH PQKM update
- Assess the impact of CDER’s IR Proof of Concept project focus on innovative near real-time collaboration capabilities
Speaker(s)
CDER Informatics Platform Modernization Strategy Update
Representative Invited
FDA, United States
CBER Modernization Update
Representative Invited
FDA, United States
FDA Electronic Submissions Gateway (ESG) NextGen Update
Representative Invited
FDA, United States
ICH Pharmaceutical Quality Knowledge Management (PQKM) Tech Platform Task Force Update
Representative Invited
FDA, United States
CDER IR Proof of Concept Update
Jonathan Resnick, PMP
FDA, United States
Project Management Officer, OBI, OSP, CDER