This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.
Abstract Details
Activity Number:
|
330
|
Type:
|
Topic Contributed
|
Date/Time:
|
Tuesday, August 3, 2010 : 10:30 AM to 12:20 PM
|
Sponsor:
|
Biopharmaceutical Section
|
Abstract - #307585 |
Title:
|
Prospective Safety Analysis Plans: Critical Elements and Principles
|
Author(s):
|
George Rochester*+
|
Companies:
|
FDA
|
Address:
|
Bldg 21 Room 4626, Silver Spring, MD, 20903, USA
|
Keywords:
|
Safety-analysis ;
risk-management ;
guidances
|
Abstract:
|
The Program Safety ANalysis Plan (PSAP) is an important tool for communication between sponsors and regulators on prospective safety planning during product, drug or biologic, developemnt. This presentation focuses on prospective planning from data collection, submission, analysis and presentation in a new product application. The critical elements that are expected in preparing a PSAP and the essential milestones for communication with the FDA are highlighted. The pre-market risk assessment forms the basis for good risk managemnt. Therefore, connections between the PSAP and other risk management activities will be clarified. Examples from real examples will be presented.
|
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 2010 program
|
2010 JSM Online Program Home
For information, contact jsm@amstat.org or phone (888) 231-3473.
If you have questions about the Continuing Education program, please contact the Education Department.