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Role of Clinical Pharmacology Guidances and Policies in Enhancing Drug Development
Session Chair(s)
Anuradha Ramamoorthy, PHARMD, PHD
Policy Lead, OCP, OTS, CDER, FDA, United States
Clinical pharmacology informs dose selection, dose optimization, and therapeutic individualization. Effective clinical pharmacology guidances and policies support an efficient drug development process and consistent regulatory evaluation.
Learning Objective : Describe the value of clinical pharmacology guidances and policies in drug development;Recognize the lifecycle approach supporting the development and implementation of clinical pharmacology guidances; Discuss the role of regulatory research and other stakeholder input in the development of clinical pharmacology guidances and policies.
Speaker(s)
Rajanikanth Madabushi, PHD
Associated Director for Guidance and Scientific Policy, OCP, OTS, CDER , FDA, United States
Role of Guidance and Policy in Advancing Clinical Pharmacology
Samantha Roberts, PHD
Senior Director, Regulatory Intelligence, AstraZeneca, United States
Advancing Clinical Pharmacology Through Regulatory Policy and Partnership
Kathleen M. Giacomini, PHD
Dean, School of Pharmacy, Professor and Principal Investigator, University of California San Francisco, United States
Academia Update
David Boulton, PHD
Clinical Pharmacology and Quantitative Pharmacology Head of Post Marketing, AstraZeneca, United States
Panelist
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