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Update from the FDA-EMA Parallel Assessment Pilot

Track:
Pharmaceutical Quality

Day & Time:
June 18, 10:30AM - 12:00PM (Pacific Standard Time)

Session Number:
343

Room Number:
10

Level:
Intermediate

Type:
Session

Title:
Update from the FDA-EMA Parallel Assessment Pilot

Chair(s):
Christine M. V. Moore, PhD
Acting Director, Office of New Drug Quality Assessment, OPS, CDER
FDA, United States

Description:
In 2011, FDA and EMA established a pilot program for parallel assessment and consultative advice of applications containing quality by design (QbD) elements. Based on the joint experiences and learning from these applications, several Question and Answer documents have been published, addressing topics such as Criticality, Design Space Verification, and Level of Detail in Applications. This session will provide an update on the EMA-FDA pilot for QbD and a discussion of the resulting Q&A documents. Regulatory authorities from the US and Europe will provide an overview of lessons learned and continued efforts toward harmonization. Additionally, the PMDA will give their views of the published Q&A documents.

Learning Objective(s):
Discuss the lessons learned from the pilot for quality by design (QbD) including how they can be applied to QbD-based applications.

Presentation(s) & Speaker(s):
EMA Perspective
Evdokia Korakianiti, PhD, MSc
Head of Procedure Management
European Medicines Agency, European Union, United Kingdom

PMDA Perspective
Yoshihiro Matsuda
Deputy Division Director, Office of Standards and Guidelines Development
Pharmaceuticals and Medical Devices Agency (PMDA), Japan