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Session Chair(s)
Evdokia Korakianiti, PHD, MSC
Head of Quality and Safety of Medicines
European Medicines Agency, Netherlands
Learning Objective : Identify the different options that the pilot offers and how they can be used to facilitate global submission and review of QbD based applications; Discuss with Regulators the key lessons learned and hear from industry members who have participated in the pilot.
Speaker(s)
Update from the EMA-FDA QbD Pilot: Consultative Advice
Elaine Morefield, PHD, RPH
VaxForm, LLC., United States
Vice President, Regulatory Affairs
Update from the EMA-FDA QbD Pilot Parallel Assessment
Evdokia Korakianiti, PHD, MSC
European Medicines Agency, Netherlands
Head of Quality and Safety of Medicines
Industry Experience
Antoinette Paone, MBA, MSC
Generation Bio, United States
Head of Regulatory Affairs
Industry Experience
John Groskoph, MBA
Pfizer Inc, United States
Executive Director, Global CMC
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