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Session 5 Track 2: A Review of Changes GDUFA Has Brought to the ANDA Process and the Regulatory Business Impact
Session Chair(s)
Emily Onkka
Senior Director, Regulatory Affairs
Pfenex, Inc., United States
Learning Objective : 1) Describe impact of GDUFA on electronic publishing and document standards for a large Generics organization. 2) Discuss the procedural changes and program initiated to change the organization’s approach to dossier development.
Speaker(s)
Impact of GDUFA on Electronic Publishing in a Large Generics Organization
Jennifer Costello
Bristol-Myers Squibb, United States
Associate Director, Global Dossier Management
GDUFA: 2 1/2 years later... Impact & Importance
Georgia Hizon
APP Pharmaceuticals / Fresenius Kabi USA, United States
Manager, Regulatory Publications
Regulatory Operations Crash Course in GDUFA
Emily Onkka
Pfenex, Inc., United States
Senior Director, Regulatory Affairs
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