Advertising and Promotion Regulatory Affairs Conference

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

Session Chair(s)

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)

Labeling for Devices Panel

Global Labeling Consultant , Opus Regulatory, United States

Speaker