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Jan 29, 2019 12:30 PM - Jan 29, 2019 1:30 PM

Online

Navigating Key FDA Advertising and Promotion Developments in a New Year

Overview

To kick off the new year, and as a prelude to DIA’s Advertising and Promotion Regulatory Affairs Conference, join us to learn about the most recent developments in the landscape of FDA advertising and promotion and how they impact your company’s marketing and communications plans. During this webinar, we will begin with a brief year in review of the latest regulatory activities in this space, followed by a deeper dive into emerging regulations and policies for DTC communications. Key topics include FDA’s recent draft guidance on quantitative information, disclosure of risk information, and FDA’s proposed framework for “prescription drug-use-related” software.

Featured topics

  • 2018 Year in Review
  • FDA’s newest draft guidance, Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements
  • Evolving approaches to disclosing risk information in DTC advertising and promotion in different media, including looming changes to the “major statement” in DTC TV advertising
  • FDA’s proposed framework for outputs of “prescription drug-use-related software” as promotional labeling

Who should attend?

Professionals who work in the area of:

  • Regulatory Affairs
  • Marketing
  • Communications
  • Compliance
  • Medical Information and Affairs
  • Legal
  • Senior Management

Learning objectives

At the conclusion of this webinar, participants should be able to:

  • Identify the latest advertising and promotion developments, including OPDP enforcement trends, drug price transparency, and recent guidances
  • Implement appropriate presentations of quantitative efficacy and risk information in DTC promotion
  • Evaluate different approaches for disclosing risk information in various DTC media platforms
  • Understand FDA’s proposed framework for the output and related functionality of “prescription drug-use-related software”
  • Enhance learning and practical application of evolving FDA advertising and promotion developments and practices


Continuing Education Credits are not available for this event.

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