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Update from the FDA-EMA Parallel Assessment Pilot
Session Chair(s)
Christine Moore, PhD
Executive Director, Global External Advocacy and Standards
Organon & Co., United States
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 : Discuss the lessons learned from the pilot for quality by design (QbD) including how they can be applied to QbD-based applications.
Speaker(s)
EMA Perspective
Evdokia Korakianiti, PhD, MSc
European Medicines Agency, Netherlands
Head of Quality and Safety of Medicines
PMDA Perspective
Yoshihiro Matsuda, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Senior Scientist (for Quality), Pharmacist
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