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QUALITY BY DESIGN (QBD) AND INNOVATION IN DEVELOPMENT AND MANUFACTURING

Track:
Pharmaceutical Quality in the 21st Century

Day & Time:
March 27, 9:00AM - 10:30AM (Central European Standard Time)

Session Number:
1205

Room Number:
Room K

Type:
Session

Title:
QUALITY BY DESIGN (QBD) AND INNOVATION IN DEVELOPMENT AND MANUFACTURING

Chair(s):
Graham Cook, PhD
Senior Director, Global Quality Strategy
Pfizer, United Kingdom

Description:
Are we at a crossroads on the journey for the adoption of the New Quality Paradigm, also known as Quality by Design (QbD)? This session will examine the current progress and challenges with the adoption of QbD in Europe and Japan and explore next steps from industry and regulatory perspectives.

Presentation(s) & Speaker(s):
QbD Approach and Regulatory Challenges in Japan
Yoshihiro Matsuda
Deputy Division Director, Office of Standards and Guidelines Development
Pharmaceuticals and Medical Devices Agency (PMDA), Japan

QbD approach and Regulatory Challenges in Europe
Peter Richardson
Head of Quality, Human Medicines Evaluation Division
European Medicines Agency, European Union, United Kingdom

QbD: Where next? – Industry experience and perspective
Frank Montgomery, PhD
Global Head, Regulatory CMC
AstraZeneca, United Kingdom