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Advertising and Promotion Regulatory Affairs Conference

This event is now offered in a new entirely virtual format.


Session 9: Track A: Labeling Changes and the Impact on Medical Devices

Session Chair(s)

Madhavi  Bellamkonda, MSc

Madhavi Bellamkonda, MSc

  • Director Regulatory Affairs, Advertising & Promotion
  • Abbott, United States

This session will be an engaging and interactive session that will focus on the impact of labeling changes in the medical device industry. Specifically, the panel will delve into three aspects:

  • Clinical trial data updates within labeling / not within labeling and impact on promotional claims
  • Labeling changes and impact on Important Safety Information for Class III combination medical
  • Planning and market implementation of a labeling change for a successful product launch
  • Learning Objective :

    Participants should be able to:

    • Assess how to incorporate new clinical trial data in promotional material before label updates
    • Describe labeling changes that impact Important Safety Information
    • Define effective product launch strategies, such as direct-to-patient marketing and social media launch strategies, when using new clinical trial data
    • Discuss the who, how, when, and where for a successful product launch with a new label

    Speaker(s)

    Gerrit  Nijveldt, MSc

    Labeling for Devices Panel

    Gerrit Nijveldt, MSc

    • EASi, United States
    Madhavi  Bellamkonda, MSc

    Speaker

    Madhavi Bellamkonda, MSc

    • Director Regulatory Affairs, Advertising & Promotion
    • Abbott, United States

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