DIA
Drug Information Association Logo

Development and Implementation of Product Safety Statistical Analysis Plans

Time

Tue, Jun 17 7:15AM
T 01

Title

Development and Implementation of Product Safety Statistical Analysis Plans

Abstract Summary

The creation of a standard operating procedure (SOP) describing the development of a Product Safety Statistical Analysis plan (PSSAP), as well as a PSSAP template, was a cross functional effort (Pharmacovigilance, Statistics, Clinical, Project Management, Regulatory) at AbbVie in 2013.

Poster Presenter

Barbara A. Hendrickson
MD,
Senior Medical Director,
AbbVie Inc.
United States