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Session Chair(s)
Mark Ammann, PHARMD
President
Quantum Regulatory Solutions, LLC, United States
Learning Objective : Discuss the critical nature of planning for health authority meetings to ensure the best possible outcome; Present best practices from experienced regulatory strategy professionals; Provide some example planning tools to facilitate preparation activities.
Speaker(s)
Getting it Right the First Time: Points to Consider in Preparing for Health Authority Meetings
Mark Ammann, PHARMD
Quantum Regulatory Solutions, LLC, United States
President
Successful Meetings with CDER (FDA): Do's and Don’ts
Luz E. Rivera, DRSC, MED, MS
FDA, United States
Regulatory Health Project Manager, ONDQA, OPS, CDER
Meetings: Pathways to Success, a European Perspective
Robert T. Clay
Highbury Regulatory Science, United Kingdom
Managing Director
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