DIA 2013 49th Annual Meeting
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Key Learnings from the Approval and Launch of a 505(b)(2) Product from a Medical Communications Perspective
Track
:
Track 06: Medical Communication, Medical Writing and Medical Science Liaison
Program Code:
404
Date:
Thursday, June 27, 2013
Time:
9:00 AM to 10:30 AM
EST
Location:
104AB
CHAIR
:
Tamar S. Yarkoni, PharmD,RPh (SCHNON), Senior Manager, Medical Information Services, Sanofi US, United States
SPEAKER
(S):
Tamar S. Yarkoni, PharmD,RPh (SPKNON), Senior Manager, Medical Information Services, Sanofi US, United States
Description
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.
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.
This session is a part of:
This session is a part of: