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Tracking Misuse and Abuse of Marketed Products: Is Pharma Doing All that It Can?
Program Code:
413
Date:
Thursday, June 27, 2013
Time:
9:00 AM to 10:30 AM
EST
CHAIR
:
Mitch Miller, PharmD (SCHNON), Director, Publications and Medical Writing, Drug Safety Alliance, Inc., United States
SPEAKER
(S):
Barbara Leishman,
MA (SCHNON), External Business Alliance Leader,
F. Hoffmann-La Roche Ltd., Switzerland
Barbara has over 30 years experience in the pharmaceutical industry, primarily in clinical drug development. In Roche, she has been responsible for numerous regional and global regulatory submissions. She is currently responsible for external business alliances in Roche Clinical Quality
|
Rick L. Seibert,
MBA,MS,PMP (SPKNON), Vice President, Project Management and New Business Development and Engineering,
Sharp Corporation, United States
Over 25 years of experience in product development, project mangement, and business development in the Medical Device, Surgical Instrument, and Specialty Packaging Services Industries. Currently working on implementing technology based serialization and brand security solutions.
|
Juliane Mills,
(SPKNON), Senior Project Manager,
United BioSource Corporation, United States
Juliane is a Senior Project Manager in at United BioSource Corporation where she manages activities related to Risk Management and post-marketing regulatory commitments,including data analyses,Risk Evaluation and Mitigation Strategy (REMS) development, and the conduct of observational studies.
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Description
This session will discuss if pharmaceutical companies are doing all that they can to ensure accurate communication of the risks involved in misuse of certain medications, and if they are appropriately tracking all adverse event reports received as a result of product misuse. This session will focus on the best practices involved in monitoring, tracking and reporting off-label use and misuse and abuse of pharmaceutical products.