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Session 5: Strategic Labeling Approaches
Session Chair(s)
Paula Hudson, RPh, RAC
Director, Global Labeling
Eli Lilly and Company, United States
Labeling associates can provide value to their organizations by working with key stakeholders early in the product development stages to develop labeling that can help with market entry and product differentiation. This session will provide some examples on how this can be accomplished.
Learning Objective :
At the conclusion of this session, participants should be able to:
- Understand how companies can set themselves up to collect the best information for initial labeling and beyond
- Understand the stakeholders needed to develop competitive labeling
- Understand the best areas of the label to leverage for market differentiation
Speaker(s)
Early Phase Drug Labeling Development
Michael Roesner, MS
Eli Lilly and Company, United States
Senior Labeling Associate
Global Target Labeling
Maria Sandrino Meinz, MS
Bayer Healthcare Pharmaceuticals, United States
Deputy Director Labeling, Global Labeling
Integrating Health Literacy into the Development of Patient Labeling and Promotional Material
Karen L. Ciprero, MS
Merck & Company Inc., United States
Director, Global Labeling
Integrating Health Literacy into the Development of Patient Labeling and Promotional Material
Kevin Stark, MBA, RAC
Mallinckrodt, United States
Executive Director, Regulatory Affairs
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