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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)
Sandra Krogulski, MA
Director, GRSO Innovation and Business Operations Lead, Bristol Myers Squibb, United States
Submitting Ad Promo in eCTD: Tips and Tricks
Thomas Christensen, RAC
Senior Regulatory Affairs Manager, SynteractHCR, United States
Lessons Learned for First-Time OPDP Submissions, Promotional Material, and Labeling
William P Liston
Sr. Submisison Speciaist, Regeneron, United States
Transitioning to eCTD for Ad Promo Submissions
Olga Alfieri, MBA, MSC, RAC
Senior Director, Global Submission Management & Operations, Eisai Co., Ltd., United States
Key Considerations in Establishing an End-to-End Process for FDA M1 AdPromo eCTD Submissions Process Prior to Implementation
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