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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)
Role of Guidance and Policy in Advancing Clinical Pharmacology
Rajanikanth Madabushi, PhD
FDA, United States
Associated Director for Guidance and Scientific Policy, OCP, OTS, CDER
Advancing Clinical Pharmacology Through Regulatory Policy and Partnership
Samantha Roberts, PhD
Genentech, A Member of the Roche Group, United States
Group Director, US Regulatory Science
Academia Update
Kathleen M. Giacomini, PhD
University of California San Francisco, United States
Dean, School of Pharmacy, Professor and Principal Investigator
Panelist
David Boulton, PhD
AstraZeneca, United States
Clinical Pharmacology and Quantitative Pharmacology Head of Post Marketing
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