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Session 12: FDA’s Guidance on Electronic Submissions of Promotional Materials
Session Chair(s)
Jason Cober, MPA
Lead Project Manager
OPDP | OMP | CDER | FDA, United States
Join members of FDA’s Office of Prescription Drug Promotion (OPDP) and an industry representative as they provide in-depth insight and advice regarding the submission of promotional materials in electronic Common Technical Document (eCTD) format to OPDP. FDA will provide a brief overview of the Providing Regulatory Submissions in Electronic and Non-Electronic Format—Promotional Labeling and Advertising Materials for Human Prescription Drugs draft guidance, review selected portions of the guidance in detail, and provide helpful technical tips for successfully submitting promotional materials to FDA as described in the guidance. An example of how one firm transitioned to eCTD will be shared. The presentation will wrap-up with a brief Q&A session.
Learning Objective : - Recognize the binding requirements and non-binding recommendations included in the FDA’s Guidance on Electronic Submissions of Promotional Materials
- Utilize recommended best practices based on FDA’s experience since the publication of OPDP’s Draft Electronic Submissions Guidance
- Describe company best practices for conversion to eCTD for Promotional Submissions
Speaker(s)
Panelist
Jason Cober, MPA
OPDP | OMP | CDER | FDA, United States
Lead Project Manager
Panelist
Josephine Secnik, MBA, MS
Eli Lilly and Company, United States
Director – Ad/Promo Regulatory Affairs
Panelist
KEMI ASANTE, PharmD, MPH, RAC
FDA, United States
POLICY ANALYST