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Cooperation Among Regulators: Impact on Stakeholders
Program Code:
135
Date:
Monday, June 24, 2013
Time:
2:30 PM to 4:00 PM
EST
CHAIR
(S):
Marie Allison Dray,
MA,MBA (SCHNON), President,
International Regulatory Affairs Group LLC, United States
Marie Dray is a pharmaceutical executive with more than twenty five years experience in regulatory affairs in Washington DC and Brussels Belgium, including strategic product actions, advisory committee preparations/evaluations, regulatory policy development and professional communications.
|
Murray M. Lumpkin,
MD,MSc (SCHAGY), Senior Fellow,
Bill and Melinda Gates Foundation, United States
23-yr FDA official. Advises Comm on interactions with counterpart frgn agencies, embassies, multinational organizations, harmonization & tech coop, & 13 frgn posts which he lead the establishment of Previously Dep Comm for Intl Prgrms, Dep Center Dir CDER, & Dir Anti-infective Drug Prdcts
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SPEAKER
(S):
She is the 21st Commissioner of Food and Drugs and leader of the U.S. FDA. A medical doctor, scientist and public health executive, Dr. Hamburg is dedicated to strengthening FDA programs and policies that enable the agency to carry out its ultimate mission — to promote and protect the public health.
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Emer Cooke, MBA (SPKAGY), Head of International and European Cooperation, European Medicines Agency, European Union, United Kingdom
Paul Glover, MBA (SPKAGY), Assistant Deputy Minister of the Health Products and Food Branch, Health Canada, Canada
Description
In this session, the audience will hear views from the leaders of three of the most influential drug regulatory agencies - The Health Products and Food Branch of Health Canada, the European Medicines Agency and the US FDA - on important issues.