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Session Chair(s)
Tamar S. Yarkoni, PHARMD, RPH
Senior Manager, Medical Information Services
Sanofi US, United States
Learning Objective : Discuss what a 505(b)(2) application is in the pharmaceutical industry; Describe the cross-functional involvement of medical information during the development of medical materials for a 505(b)(2) product; Discuss the unique opportunities and learning experiences attained during the period leading up to approval and launch of a new drug/device combination product.
Speaker(s)
Introduction to 505(b)(2) Approved Products: How are They Different From Other Approved Products? How Do I Prepare for a Product Launch?
Tamar S. Yarkoni, PHARMD, RPH
Sanofi US, United States
Senior Manager, Medical Information Services
Case Studies From Contact Centers Launching 505(b)(2) Approved Products
David Bowers, PHARMD
PPD, United States
Senior Director, Operations
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