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Bethesda North Marriott Hotel and Conference Center

2025 年 02 月 03 日 7:45 上午 - 2025 年 02 月 05 日 12:45 下午

5701 Marinelli Road, North Bethesda, MD 20852

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)!

Advanced Rates Expire

DAYS

HOURS

MINUTES

SECONDS

Session 3: FDA Plenary: Data and Technology Strategy

Session Chair(s)

Seyoum  Senay, MS

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
  • 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)

Sri  Mantha, MBA, MS

CDER Informatics Platform Modernization Strategy Update

Sri Mantha, MBA, MS

FDA, United States

Director, Office of Strategic Programs

Robert Troy Reisch

CBER Modernization Update

Robert Troy Reisch

FDA, United States

Director, Division of Information Technology, CBER

Representative Invited

FDA Electronic Submissions Gateway (ESG) NextGen Update

Representative Invited

FDA, United States

Ranjit Mathew Thomas, MBA

ICH Pharmaceutical Quality Knowledge Management (PQKM) Tech Platform Task Force Update

Ranjit Mathew Thomas, MBA

FDA, United States

Associate Director CDER

Jonathan  Resnick, PMP

CDER IR Proof of Concept Update

Jonathan Resnick, PMP

FDA, United States

Project Management Officer, OBI, OSP, CDER

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