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DIA 2021 Global Annual Meeting


Role of Clinical Pharmacology Guidances and Policies in Enhancing Drug Development

Session Chair(s)

Anuradha  Ramamoorthy, PhD

Anuradha Ramamoorthy, 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

Role of Guidance and Policy in Advancing Clinical Pharmacology

Rajanikanth Madabushi, PhD

  • Associated Director for Guidance and Scientific Policy, OCP, OTS, CDER
  • FDA, United States
Samantha  Roberts, PhD

Advancing Clinical Pharmacology Through Regulatory Policy and Partnership

Samantha Roberts, PhD

  • Group Director, US Regulatory Policy
  • Genentech, A Member of the Roche Group, United States
Kathleen M. Giacomini, PhD

Academia Update

Kathleen M. Giacomini, PhD

  • Professor, Bioengineering and Therapeutic Sciences; CERSI Co-Director
  • University of California San Francisco, United States
David  Boulton, PhD

Panelist

David Boulton, PhD

  • Clinical Pharmacology and Quantitative Pharmacology Head of Post Marketing
  • AstraZeneca, United States