DIA 2013 49th Annual Meeting
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Lessons Learned from the EMA-FDA Quality by Design (QbD) Pilot
Track
:
Track 12: Pharmaceutical Quality
Program Code:
279
Date:
Tuesday, June 25, 2013
Time:
4:00 PM to 5:30 PM
EST
Location:
153C
CHAIR
:
Evdokia Korakianiti, PhD,MSc (SCHAGY), Head of Chemicals Section, Quality of Medicines, European Medicines Agency, European Union, United Kingdom
SPEAKER
(S):
Elaine Morefield, PhD (SPKAGY), Deputy Office Director, Office of New Drug Quality Assessment, OPS, CDER, FDA, United States Evdokia Korakianiti, PhD,MSc (SPKAGY), Head of Chemicals Section, Quality of Medicines, European Medicines Agency, European Union, United Kingdom
John Groskoph, MBA (SPKNON), Senior Director, Global CMC, Pfizer Inc, United States
Antoinette Paone, MBA,MSc (SPKNON), Senior Director, Global CMC Regulatory Affairs Strategy, Vertex Pharmaceuticals, United States
Description
This session will present the EMA-FDA quality by design pilot. The presentations will describe the two review pathways available under the pilot, i.e. parallel assessment and consultative advice. The purpose of the pilot, the application process and the review procedures will be described. The key lessons learned from the applications received so far will be discussed. There will be also a panel discussion with the speakers and some industry representatives that have participated in the pilot.
This session is a part of:
This session is a part of: