CHAIR
:
SPEAKER
(S):
Sheryl Lard-Whiteford, PhD, is the Associate Director for Quality Assurance in the Center for Biologics Evaluation and Research at the FDA. In this capacity she serves as CBER's Ombudsman, Chief Jurisdiction Officer, and supervisor for the center’s internal quality assurance efforts.
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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.