Drug Information Association Logo
« Back to Listing

Health Authority Meeting Preparation: There Are No Do-Overs

Track:
Regulatory Affairs and Submissions

Day & Time:
June 18, 3:30PM - 5:00PM (Pacific Standard Time)

Session Number:
388

Room Number:
5B

Level:
Intermediate

Type:
Session

Title:
Health Authority Meeting Preparation: There Are No Do-Overs

Chair(s):
Mark A. Ammann, PharmD
President
Catalyst Regulatory Services, LLC, United States

Description:
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(s):
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.

Presentation(s) & Speaker(s):
Getting it Right the First Time: Points to Consider in Preparing for Health Authority Meetings
Mark A. Ammann, PharmD
President
Catalyst Regulatory Services, LLC, United States

Successful Meetings with CDER (FDA): Do's and Don’ts
Luz E. Rivera, DrSc, MEd, MS
Regulatory Health Project Manager, ONDQA, OPS, CDER
FDA, United States

Meetings: Pathways to Success, a European Perspective
Robert T. Clay, MBA, MSc
Managing Director
Highbury Regulatory Science Limited, United Kingdom