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Wednesday, June 27 • 4:00pm - 5:15pm
#395: PDUFA VI: Improving Transparency and Accountability of Electronic Submission and Data Standards Activities

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-684-L04-P; CME 1.25; IACET 1.25; RN 1.25

FDA is committed to achieve the long-term goal of improving the predictability and consistency of the electronic submission process and enhancing transparency and accountability of FDA information technology related activities. The PDUFA VI Section IV Information Technology goals focus on following areas: 1. Electronic Submission process from Gateway (ESG) to FDA Center, 2. Technical rejection of submissions process and validation criteria, 3. Electronic system status, performance and metrics, and 4. Data standards, adoption and conformance. This session will provide an overview of the FDA electronic submission systems and data standards that impact sponsors applications from time of submission at the ESG through the time the submission is made available to the review team.

Learning Objectives

Describe the electronic submission process including key milestones; Explain the electronic submission gateway submission upload timeframes, notifications to sponsors and rejection process; Discuss the data standards catalog and action for industry.

Chair

Ron D. Fitzmartin

Speaker

FDA Update
Virginia Hussong

FDA Update
Ethan Chen, MBA


Speakers
avatar for Ethan Chen

Ethan Chen

Director, Division of Data Management Services and Solutions, OBI, OSP, CDER, FDA
Ethan Chen provides overall leadership to CDER in streamlining electronic and traditional submissions and delivering solutions to enable rapid adoption of emerging electronic data standards. Since joining the FDA in 2012, Mr. Chen has led the several critical initiatives as the CDER... Read More →
avatar for Ron Fitzmartin

Ron Fitzmartin

Senior Informatics Advisor, Office of the Director, CBER, FDA
Ron Fitzmartin is Senior Informatics Advisor, Office of the Director, Center for Biologics Evaluation and Research, Food and Drug Administration. In this role Ron provides policy and strategy consultation and support on a wide range of topics focused on electronic regulatory submissions... Read More →
avatar for Virginia Hussong

Virginia Hussong

Chief, Data Standards Program, CBER, FDA
Ginny Hussong is Chief of CBER’s Data Standards Program, and has been with FDA for 14 years. She was previously Director of Data Management Services and Solutions within CDER. As Chair of CBER’s Data Standards Committee, Ginny’s recent projects include creating a new joint data... Read More →

Wednesday June 27, 2018 4:00pm - 5:15pm
Room 205C Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  09: Regulatory, Session