|
Activity Number:
|
119
|
|
Type:
|
Invited
|
|
Date/Time:
|
Monday, July 30, 2007 : 10:30 AM to 12:20 PM
|
|
Sponsor:
|
Biopharmaceutical Section
|
| Abstract - #310427 |
|
Title:
|
Safety First: Managing Patients' Safety and Mitigating Products' Risks
|
|
Author(s):
|
Christy Chuang-Stein*+
|
|
Companies:
|
Pfizer Inc.
|
|
Address:
|
2800 Plymouth Road, Ann Arbor, MI, 48105,
|
|
Keywords:
|
|
|
Abstract:
|
Protecting patient's safety and ensuring that benefit outweighs risk are the guiding principles in selecting treatments for patients and conducting medical experimentation. These principles were solidified in the 1948 Nuremberg Code and reinforced in the 1964 Declaration of Helsinki. The 1997 Belmont Report further reminded researchers of the need to treat subjects in an ethical manner by respecting their decisions and protecting them from harm. The above mandates monitoring safety in clinical trials and managing product safety. Increasingly, risk management plans are employed to mange marketed products (e.g., thalidomide, Lotronex and Accutane) whose usage could only be justified in a subpopulation. In this presentation, we will review the role safety evaluation plays in product assessment and the role such assessment occupies in various Prescription Drug User Fee Acts.
|
- The address information is for the authors that have a + after their name.
- Authors who are presenting talks have a * after their name.
Back to the full JSM 2007 program |
