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Formal Dispute Resolution at CDER: When, Why, and How

Track:
Public Policy/Health Care Compliance/Law

Day & Time:
June 16, 8:30AM - 10:00AM (Pacific Standard Time)

Session Number:
113

Room Number:
11B

Level:
Intermediate

Type:
Session

Title:
Formal Dispute Resolution at CDER: When, Why, and How

Chair(s):
Kim M. Quaintance
Head, US Regulatory Policy
Bayer HealthCare Pharmaceuticals, United States

Description:
Your company has received a decision from CDER on an important issue. Your team reviews the decision, and does not agree with CDER. What do you do now? Is formal dispute resolution an option, and if it is, is it the best option? The speakers, all with first-hand experience with this process, will discuss the strategy for requesting formal dispute resolution with CDER. The presentations will provide information on when to undertake formal dispute resolution, and when to consider other pathways. Audience members will learn how to successfully navigate the process, including the critical nature of a well written request. Finally, the panelists will go beyond the granted or denied decision and discuss what constitutes a positive outcome. This session will include a case study of a disputed decision.

Learning Objective(s):
Recognize when formal dispute resolution is a viable option for a drug development program; Describe how to successfully navigate the formal dispute resolution process; Identify positive outcomes of the formal dispute resolution process.

Presentation(s) & Speaker(s):
We Disagree: Is Formal Dispute Resolution an Option?
Kim M. Quaintance
Head, US Regulatory Policy
Bayer HealthCare Pharmaceuticals, United States

Strategy for Discussing Formal Dispute Resolution
Josephine Torrente, JD, MS
Attorney
Hyman, Phelps & McNamara, P.C., United States