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Key Learnings from the Approval and Launch of a 505(b)(2) Product from a Medical Communications Perspective
Session Chair(s)
Tamar S. Yarkoni, PharmD, RPh
Senior Manager, Medical Information Services
Sanofi US, United States
This session will discuss the concept of a 505(b)(2) application. It will be compared/contrasted to a New Drug Application (NDA) for a pharmaceutical product. The responsibilities of preparing for, launching and supporting various types of medical products including drugs and devices after approval via 505(b)(2) application will be discussed.
There are unique opportunities and challenges associated with supporting devices, vaccines and diagnostic tools in the pharmaceutical industry; these will be described and general examples will be provided.
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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