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DIA 2013 49th Annual Meeting
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Is There a Disagreement? We Can Help - Dispute Resolution between Industry and US/EU Regulators
Track : Track 08:Regulatory Affairs and Submissions
Program Code: 111
Date: Monday, June 24, 2013
Time: 11:00 AM to 12:30 PM  EST
Location: 253B
CHAIR :
 Virginia L. Behr, (SCHAGY), Ombudsman, Office of Executive Programs, CDER, FDA, United States
SPEAKER (S):
 Sheryl L. Lard Whiteford, PhD (SPKAGY), Associate Director for Quality Assurance, Ombudsman,CBER, FDA, United States
Virginia L Behr, (SPKAGY), Ombudsman, Office of Executive Programs, CDER, FDA, United States
Emer Cooke, MBA (SPKAGY), Head of International and European Cooperation, European Medicines Agency, European Union, United Kingdom
Amy Bertha, (SPKAGY), Team Leader, Office of New Drugs, Center for Drug Evaluation and Research, FDA, United States
Description
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.

Session Recording
(Code: 111)
DIA 2013 Attendee:
Attendees Login
  
This session is a part of:
DIA 2013 Live Learning Center
CON2 Comp Access: Monday Online Access Package - June 24, 2013
Handout Online
(Code: 111)
DIA 2013 Attendee:
Attendees Login
  
This session is a part of:
DIA 2013 Live Learning Center
CON2 Comp Access: Monday Online Access Package - June 24, 2013
Is There a Disagreement? We Can Help - Dispute Resolution between Industry and US/EU Regulators