Ad/Promo eCTD Submissions Round Table

On-Demand Content Preview Webinar


In this webinar...

The Ad/Promo eCTD Submissions Round Table will present the experiences and perspectives of three companies who have transitioned their Ad/Promo submission process to eCTD format. The panel will feature representatives from Eli Lilly, Otsuka, and Agios, and will be moderated by the Office of Prescription Drug Promotion. Each panel member will provide an overview of their path to Ad/Promo eCTD adoption while also discussing challenges and lessons learned along the way. The panel will conclude with a Q&A session.

Learning Objectives

At the conclusion of this webinar:

  • Companies who have not yet transitioned their Ad/Promo submission process to eCTD will be able to compare strategies and solutions for converting the Ad/Promo submission process to eCTD format
  • Companies who have transitioned or are the in process of transitioning their Ad/Promo submission process to eCTD will be able to evaluate and compare their existing process to other successful strategies
  • Participants will be able to identify and integrate best practices based on lessons learned through successful eCTD implementation

Presenters

  • Jason Cober, MPA, Lead Project Manager, US FDA/Office of Prescription Drug Promotion (OPDP)
  • Josephine Secnik, Director, Regulatory Affairs, Eli Lilly and Company
  • Joanne Hathaway, Manager, Otsuka Pharmaceutical Development and Commercialization Inc.
  • Riley Stelzer, PharmD, Manager, Regulatory Affairs Advertising, Promotion and Labeling, Agios Pharmaceuticals, Inc.
  • Suzanne Libby, MS, Associate Manager, Regulatory Operations, Agios Pharmaceuticals, Inc.