DIA 48th Annual Meeting
Click here to go to the previous page
Quality by Design in Clinical Development: Blessing or Burden?
Track
:
Track 02: Project/Portfolio Management and Strategic Planning
Program Code:
127
Date:
Monday, June 25, 2012
Time:
1:30 PM to 3:00 PM
EST
CHAIR
:
Barbara Leishman, F. Hoffmann-La Roche Ltd., Switzerland
PRESENTER
(S):
Jeffrey Kasher, Eli Lilly and Company, United States Leslie Ball, FDA, United States Kenneth Sprenger, Pfizer Inc, United States
Description
By reviewing current regulatory and industry initiatives, this session aims to provide clarity in a changing environment, and provide the impetus and information to support those seeking to apply QbD/QRM to add value in their own environment.
Learning Objectives:
Elucidate regulators' expectations in application of QbD/QRM in clinical development
Assess the different targets for application of QbD/QRM in clinical development in industry
Explain how QbD/QRM adds value as a cross-functional activity throughout the clinical development life cycle.
Learning Objectives:
Elucidate regulators' expectations in application of QbD/QRM in clinical development
Assess the different targets for application of QbD/QRM in clinical development in industry
Explain how QbD/QRM adds value as a cross-functional activity throughout the clinical development life cycle.
This session is a part of:
Handout Online
