Get the 411 on 1.14 (It's More Than Just Compliant Labeling!)

Compliant labeling is a critical part of any marketing application. But is that enough? This session will focus on the importance of collaboration between regulatory strategy and labeling, and the associated risks of not considering labeling strategy early in a product’s development and how it can be detrimental to the product’s success. The regulatory strategy should be seen as a "living document" that is regularly revised based on scientific results, as well as on changes in the regulatory environment. Development of regulatory strategy should take place at the earliest possible stage of product development with emphasis on the key elements to ensure market success – target geographies for commercialization, regulatory requirements, product function and features, as well as the overall project timelines and milestones.

By beginning with the end in mind, companies have an opportunity to develop labeling that is not only compliant but contains content that supports key product claims and differentiators. Within this session, experts in strategy for regulatory, labeling, and label operations will discuss the role of a target product profile, when labeling and label operations should be engaged in the development process, and identify key contributors required for optimal product labeling. While the focus will be US labeling, the panel will explore key considerations and risks when leveraging US labeling to support commercialization of a product in multiple regions. The panel will discuss how each function can support the other, and why this relationship aids in more optimal product labeling.