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Electronic Submissions Demystified
Session Chair(s)
Tessa Brown, BSN, DRSC, MPH, RN
Super Office Deputy Director for Operations, DHHS/FDA/CDER/Office of Strategic Programs, United States
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 Objective : 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.
Speaker(s)
Jonathan Resnick, PMP
Advisor, Office of Digital Transformation, FDA, United States
FDA Perspective
Sandra Krogulski, MA
Senior Director, Regulatory Digital Strategy and External Engagement, Bristol Myers Squibb, United States
Submission Lifecycle Maintenance: Managing the Chaos
Julian Chun, PHARMD, MBA
Pharmacist, DRLB, OUDLC, OC, CDER, FDA, United States
Are You Prepared for the Change? New and Updated Requirements in Drug Registration and Listing
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