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Clinical Drug Development & Investigations
Symposia

Symposium 5: Contemporary Issues Related to Pediatric Drug Development

Monday, September 11, 2023
8:00 AM - 9:30 AM PT
Location:Grand Ballroom E-H
CE: 1.5

    Chair & Faculty(s)

  • MS

    Martina Sahre, PhD

    Policy Lead, Office of Clinical Pharmacology
    US Food & Drug Administration

    • Faculty(s)

  • Vikram Arya, PhD

    Associate Director, Therapeutic Review, Div of Infectious Disease Pharmacology, Office of Clinical Pharmacology
    US Food & Drug Administration

  • Jeremiah Momper, PharmD, PhD

    Professor
    Univ of California San Diego

  • Yumi Cleary, BSc, MSc

    Clinical Pharmacometrician, Principal Scientist, Roche Innovation Ctr Basel
    F. Hoffmann-La Roche Ltd

The target audience for this Symposium includes all PharmD, MD and PhD scientists in drug development.

Goals & Objectives:

Following the completion of this activity, the learner will be able to:
  • Provide an overview of areas where data is often translated from adults to pediatric patients;
  • Assess where information gaps exist.

Presentations:

  • Introduction

    Chair & Faculty: Martina Sahre, PhD – US Food & Drug Administration

  • Food Effect Assessment in Pediatrics: A Few Considerations

    Faculty: Vikram Arya, PhD – US Food & Drug Administration

  • Considerations for Neonatal Clinical Pharmacology Studies

    Faculty: Jeremiah D. Momper, PharmD, PhD – Univ of California San Diego

  • Novel Model-based Approach for Drug-Drug Interaction Risk Assessments in Children

    Faculty: Yumi Cleary, BSc, MSc – F. Hoffmann-La Roche Ltd

  • Faculty Panel Discussion, Questions & Answers, Learner Feedback & Evaluation