Associate Director, Guidance and Scientific Policy
US Food and Drug Administration
Rajanikanth (Raj) Madabushi has over 15 years of regulatory experience. As a Pharmacometrics Reviewer and Clinical Pharmacology Team Lead, Dr. Madabushi has played a key role in the advancement and application of quantitative clinical pharmacology approaches for regulatory decision making and addressing various drug development issues. He currently serves as the Associate Director, Guidance and Scientific Policy in the Immediate Office of Office of Clinical Pharmacology. Dr. Madabushi is also the CDER Point-of-Contact for the PDUFA VI MIDD Paired Meeting Pilot Program and the Rapporteur for ICH M12 Expert Working Group – Drug Interaction Studies.
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Tuesday, January 11, 2022
8:00 PM – 9:00 PM ET
Wednesday, January 12, 2022
12:00 PM – 1:00 PM ET
Monday, April 25, 2022
8:00 AM – 1:30 PM ET