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Session 8 Track 4: Ad Promo
Session Chair(s)
Thomas Noto
Senior Director, Regulatory Operations
Lexicon Pharmaceuticals, United States
The FDA AdPromo eCTD Guidance was finalized in June 2019 and becomes mandatory in June of this year! In this session you will hear from speakers who have successfully implemented AdPro eCTD in their organizations and gain a greater understanding of how it can be done in yours. The focus will be on real world lessons-learned and practical tips for a smooth transition.
Learning Objective : At the conclusion of this session, participants should be able to:
- Know the AdPromo eCTD process
- Understand the challenges and opportunities of moving from a legacy process
- Gain perspective on the context of AdPromo documents and why they are critical to your organization
Speaker(s)
Ad Promo Submissions in eCTD: Are you Ready to be Compliant?
Allison Steffen
WAYS Pharmaceutical Services, United States
Submissions Lead, Regulatory Operations
Implementing eCTD AdPromo Submissions Under a Critical Timeline
Thomas Noto
Lexicon Pharmaceuticals, United States
Senior Director, Regulatory Operations
Speaker
Melinee Wilson
Astellas Pharma Global Development, Inc., United States
Director, Regulatory Submissions