Regulatory Strategies to Facilitate Access to Global Outbreak Vaccines

4:00 PM - 5:00 PM, Monday, June 3,2019 ・ 115C, Level 100
One of the unique challenges affecting the development of new vaccines and therapeutics against pathogens with pandemic potential is the complexity of a global regulatory process. Companies and regulators, working closely with the WHO and CEPI, have deployed strategies to design clinical trials and create pathways tailored to these products, all while responding to ongoing outbreaks all over the world. This panel will focus on the unique issues of clinical and regulatory decision-making and approvals for vaccines and drugs for use in outbreak settings. Using Ebola and Lassa Fever as case studies, panelists will discuss key learnings from the current and past global responses and share how the global health community can work together to speed up our overall response in emergency situations.
Speakers
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CEO
Coalition for Epidemic Preparedness Innovations (CEPI)
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Associate Vice President, Global Vaccines Public Policy, Partnerships, and Government Affairs
Merck & Co, Inc.
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Deputy Director, Office of Vaccines Research and Review
U.S. Food and Drug Administration
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Senior Vice President, Corporate Development
Themis Bioscience GbmH