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Is There a Disagreement? We Can Help - Dispute Resolution between Industry and US/EU Regulators
Session Chair(s)
Virginia L. Behr
Ombudsman, Office of Executive Programs, CDER
FDA, United States
Sometimes conflict happens between those in regulated industry and the regulators and can arise at any time in the drug or biologic life cycle. Regulators from FDA and EMA will discuss practical ways to seek resolution.
Learning Objective : Describe informal and formal pathways (including policies and procedures) for dispute resolution for both FDA and EMA; Identify circumstances when benefit could be derived from use of dispute resolution options, including utilization of ombudsman services.
Speaker(s)
Moderator
Sheryl L. Lard Whiteford, PhD
FDA, United States
Associate Director for Quality Assurance, OCD, CBER
Approaches to Dispute Resolution with CDER/CBER and the Ombudsman’s Role
Virginia L. Behr
FDA, United States
Ombudsman, Office of Executive Programs, CDER
CDER/CBER Formal Dispute Resolution: Appeals Above the Division Level
Amy Bertha
Bayer, United States
Executive Director, Regulatory Policy and Innovation
Is there a Disagreement? We Can Help - Dispute Resolution between Industry and EU Regulators
Emer Cooke, MBA, MSc
The European Medicines Agency, Netherlands
Executive Director, Chair, ICMRA
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