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Tuesday, June 26 • 4:15pm - 5:30pm
#289: Electronic Submissions Demystified

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-617-L04-P; CME 1.25; IACET 1.25; RN 1.25

During this session, FDA and industry will provide a summary on electronic submissions. As of May 5, 2017 and May 5, 2018, eCTD is required for NDA, BLA, and ANDA and Commercial IND and DMF submissions, respectively. FDA will provide an update on submission metrics and industry will provide an overview of best practices for successful submission. Additionally, FDA will provide an update on requirements for drug registration and listing, which are intended to improve FDA and industry processes.

Learning Objectives

Discuss the status of electronic submissions and validation at the FDA; Identify key components of lifecycle management for electronic submissions; Apply proposed best practices for handling daily submissions and ensuring validation standards are followed; Describe changes to the drug registration and listing regulation; Describe how to reserve a National Drug Code and certify a drug listing file.

Chair

Tessa Brown

Speaker

FDA Perspective
Jonathan Resnick

Submission Lifecycle Maintenance: Managing the Chaos
Sandra A. Krogulski, MA

Are You Prepared for the Change? New and Updated Requirements in Drug Registration and Listing
Julian Chun, PharmD, MBA


Speakers
avatar for Tessa Brown

Tessa Brown

Deputy Director, Office of Business Informatics /OSP / CDER, FDA
CAPT Tessa Brown DHSc, MPH, BSN, RN began her career as a Commission Corp Officer of the U.S. Public Health Service (USPHS) in 2001. She has held positions in various organizations to include the Bureau of Prisons, Health Resources and Services Administration, and the Food and Drug... Read More →
avatar for Julian Chun

Julian Chun

Pharmacist, DRLS, OPRO, OC, CDER, FDA
Julian Chun is a pharmacist with the Drug Registration and Listing Staff in CDER’s Office of Compliance. Prior to his current position, Julian served in managerial and clinical roles for Johns Hopkins Outpatient Pharmacy and Giant Pharmacy. Julian received his Doctor of Pharmacy... Read More →
avatar for Sandra Krogulski

Sandra Krogulski

Regulatory Operations Submission Manager, Accenture
Sandy is a Submission Manager in Accenture’s Global Regulatory Operations team. In this role, she supports clients through life cycle maintenance through training, overseeing actual submissions and consulting. Sandy oversees the management of numerous regulatory submissions ensuring... Read More →
avatar for Jonathan Resnick

Jonathan Resnick

Project Management Officer, OBI, OSP, CDER, FDA
Jonathan Resnick is a member of CDER’s Electronic Submissions Team, with a focus on eCTD and has been with FDA for eight years. Prior to joining FDA, Jonathan spent 18 years working in IT project management supporting federal and private sector clients.

Tuesday June 26, 2018 4:15pm - 5:30pm EDT
Room 204AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  09: Regulatory, Session