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Session 2 Track 4: Ad/Promo
Session Chair(s)
Thomas Noto
Senior Director, Regulatory Operations
Lexicon Pharmaceuticals, United States
AdPromo submissions in eCTD format are now being accepted, but are still the “new reality” for many sponsors. This session will focus on the changes to the eCTD that come with the new US Module 1 specification (DTD v.3.3) and key considerations for establishing an end-to-end process for AdPromo eCTD submissions. The session will also highlight real-world and tricks for transitioning to an efficient electronic 2253 submission workflow.
Learning Objective : Analyze and simplify the complexity of the new FDA requirements Address importance of guidance is to submission success Perform the process for creating eCTD submissions for OPDP Define the Dos and Don’ts of Submissions Differentiate when to include correspondence in your submission and when not to Recognize the advantages of working closely with the FDA on this and anticipate reactions
Speaker(s)
Submitting Ad Promo in eCTD: Tips and Tricks
Sandra Krogulski, MA
Bristol Myers Squibb, United States
Director, GRSO Innovation and Business Operations Lead
Lessons Learned for First-Time OPDP Submissions, Promotional Material, and Labeling
Thomas Christensen, RAC
SynteractHCR, United States
Senior Regulatory Affairs Manager
Transitioning to eCTD for Ad Promo Submissions
William P Liston
Regeneron Inc, United States
Sr. Submisison Speciaist
Key Considerations in Establishing an End-to-End Process for FDA M1 AdPromo eCTD Submissions Process Prior to Implementation
Olga Alfieri, MBA, MSc, RAC
Eisai Pharmaceuticals, United States
Senior Director, Global Submission Management & Operations