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Bethesda North Marriott Hotel and Conference Center

2018 年 03 月 08 日 7:00 上午 - 2018 年 03 月 09 日 3:00 下午

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Advertising and Promotion Regulatory Affairs Conference

Session 12: FDA’s Guidance on Electronic Submissions of Promotional Materials

Session Chair(s)

Jason  Cober, MPA

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in Electronic and Non-Electronic Format—Promotional Labeling and Advertising Materials for Human Prescription Drugs draft guidance, review selected portions of the guidance in detail, and provide helpful technical tips for successfully submitting promotional materials to FDA as described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)

Jason  Cober, MPA

Panelist

Jason Cober, MPA

OPDP | OMP | CDER | FDA, United States

Lead Project Manager

Josephine  Secnik, MBA, MS

Panelist

Josephine Secnik, MBA, MS

Eli Lilly and Company, United States

Director – Ad/Promo Regulatory Affairs

KEMI  ASANTE, PharmD, MPH, RAC

Panelist

KEMI ASANTE, PharmD, MPH, RAC

FDA, United States

POLICY ANALYST

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