Clone of Clinical Research Education Series (CRES) “Kemi.O"
Employees at Houston Methodist Hospital.
Virtual - Zoom link with be provided to the registered participants.
Dr. Sudhakar Agnihothram, B.Pharm., Ph.D
Biologist (Primary Reviewer)
Center for Biologics Evaluation and Research
Office of Vaccines Research and Review
U.S. Food and Drug Administration
Dr. Agnihothram is Senior Reviewer at Regulatory Review Branch-2 (RRB-2, led by Dr. Rakesh Pandey), at the Division of Vaccines and Related Products Applications, Office of Vaccines Research and Review, CBER, FDA. His expertise encompasses virology/immunology and other areas of biomedical sciences. He manages product life cycle regulation of Hepatitis, CMV, Seasonal and Universal Influenza Vaccines, tropical disease vaccines including Chikungunya, Dengue, emerging virus vaccines including Lassa, Ebola, and Marburg virus vaccines. His specialty also includes regulation of COVID -19 vaccines, where he currently serves as a chair of the FDA multidisciplinary review committees responsible for Emergency Use Authorization for Moderna COVID -19 vaccine and Janssen COVID-19 Vaccine, and review committee for Moderna COVID-19 Vaccine for SPIKEVAX Biological License Application (Moderna COVID-19 Vaccine) and has been working on managing other front-line COVID-19 Vaccines.
CEs 4.0 hours
- 1.00 Attendance
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