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Wednesday, June 29 • 10:30am - 11:45am
#315: Enhancing Pediatric Product Development in a Global Regulatory Environment: Extrapolation and Modeling and Simulation, Oh My!

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Limited Capacity seats available
Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-549-L01-P; CME 1.25; IACET 1.25; RN 1.25

This forum will examine how the international regulatory community is responding to the challenge of pediatric product development (limited access to patients) with alternative strategies to generate meaningful data and enhance program efficiency.

Learning Objectives

Discuss the unique challenges and opportunities associated with development of therapies for pediatric populations; Describe how stakeholders can work together to improve the development of, evaluation of, and application of innovative strategies that will advance pediatric product development; Identify opportunities to translate policy into advances for the field of pediatric drug development.

Chair

Christina Bucci-Rechtweg, MD

Speaker

FDA Perspective
Lynne P. Yao, MD

FDA Perspective
Mary Dianne Murphy, MD

Health Canada Perspective
Ariel E. Arias

Panelist
Jordi Llinares Garcia


Chair
avatar for Christina Bucci-Rechtweg

Christina Bucci-Rechtweg

Global Head, Maternal Health and Pediatric Regulatory Policy, Novartis , United States
Christina is Global Head of Pediatric & Maternal Health Policy at Novartis. She graduated from the U Rochester Sch of Medicine & Dentistry and trained in Peds/Pediatric Critical Care Medicine at SUNY Buffalo. She has 20+ yrs of experience in Clinical Development and Regulatory Policy... Read More →

Speakers
avatar for Ariel Arias

Ariel Arias

Senior Advisor, Centre for Biologics Evaluation, BGTD, Health Canada
Dr Arias has many years of experience in the assessment of drug products. He has provided expert advice for a number of drug safety regulatory initiatives and represented Health Canada in various international drug regulatory technical committees (e.g., ICH, PAHO). He is an adjunct... Read More →
avatar for Jordi Llinares Garcia

Jordi Llinares Garcia

Head of Research and Innovation, European Medicines Agency, Netherlands
Dr Jordi Llinares is currently the Head of Research and Innovation at the European Medicines Agency (EMA). At the Agency he has had different posiitons including Head of Orphan Medicines, Scientific Support Development and, and Scientific and regualtory management between 2009 and... Read More →
MM

Mary Murphy

Director, Office of Pediatric Therapeutics, Office of Special Medical Programs, FDA
Dianne Murphy, MD, FAAP, is Director of the Office of Pediatric Therapeutics (OPT) Office of the Commissioner at FDA. Dr. Murphy was a medical officer at Bethesda Naval; Dir. of the virology laboratory at the U. of Tenn., Knoxville & tenured Professor at the U. of Florida, Jacksonville... Read More →
avatar for Lynne Yao

Lynne Yao

Director, Division of Pediatric and Maternal Health, Office of New Drugs, CDER, FDA, United States
Lynne Yao, M.D., is the Director, Division of Pediatrics and Maternal Health in the Office of New Drugs, Center for Drug Evaluation and Research. The Division of Pediatrics and Maternal Health oversees quality initiatives which promote and necessitate the study of drug and biological... Read More →

Wednesday June 29, 2016 10:30am - 11:45am EDT
201B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 08: Reg Affairs, Forum