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Implementation of Quality by Design: Progress Update

Track:
Pharmaceutical Quality

Day & Time:
June 16, 8:30AM - 10:00AM (Pacific Standard Time)

Session Number:
115

Room Number:
7A

Level:
Intermediate

Type:
Session

Title:
Implementation of Quality by Design: Progress Update

Chair(s):
Moheb M. Nasr, PhD, MS
Vice President, CMC Regulatory Strategy
GlaxoSmithKline, United States

Description:
Leading industry and regulatory speakers will share their perspectives on quality by design (QbD) implementation progress. The session will outline specific implementation strategies and progress made so far, as well as remaining regulatory and technical challenges.

Learning Objective(s):
Discuss the current state of implementation of quality by design (QbD) in the US; Describe different implementation approaches; Outline remaining technical and regulatory challenges; Make specific proposals to address identified challenges; Identify challenges of current approaches based on their own experience.

Presentation(s) & Speaker(s):
Progress and Remaining Challenges: Industry Perspective
John Groskoph, MBA
Senior Director, Global CMC
Pfizer Inc, United States

Progress and Remaining Challenges: FDA Perspective
Sarah Pope Miksinski, PhD
Director, Division II, Office of New Drug Quality Assessment, OPS, CDER
FDA, United States

EMA Perspective
Evdokia Korakianiti, PhD, MSc
Head of Procedure Management
European Medicines Agency, European Union, United Kingdom