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Health Authority Meeting Preparation: There Are No Do-Overs
Session Chair(s)
Mark Ammann, PHARMD
President, Quantum Regulatory Solutions, LLC, United States
One measure of success for health authority interaction is having no surprises. There is no way to guarantee a positive outcome. However, if you thoroughly consider the potential challenges, you can diligently prepare and present your best case. This session will describe critical success factors to preparing for health authority meetings. Perspectives will be presented by a US Regulatory Affairs professional, a European Regulatory Affairs professional as well as a representative from the US FDA.
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)
Mark Ammann, PHARMD
President, Quantum Regulatory Solutions, LLC, United States
Getting it Right the First Time: Points to Consider in Preparing for Health Authority Meetings
Luz E. Rivera, DRSC, MED, MS
Regulatory Health Project Manager, ONDQA, OPS, CDER, FDA, United States
Successful Meetings with CDER (FDA): Do's and Don’ts
Robert T. Clay
Managing Director, Highbury Regulatory Science, United Kingdom
Meetings: Pathways to Success, a European Perspective
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