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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

Head, Pediatric and Maternal Health Policy, Global Regulatory Affairs, Novartis Pharmaceuticals Corporation
Dr. Bucci-Rechtweg graduated from the University of Rochester School of Medicine & Dentistry, and received Pediatric Residency and Pediatric Critical Care Medicine Fellowship training at SUNY @ Buffalo. In her career she has designed and implemented phase II – III development programs targeting diseases affecting the pediatric population and women’s health, and now has dedicated her career to advancing global health policy initiatives... 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 professor at the Fac. Pharmacy of the Université de Montréal, an active member of the Signal Panel of the the Uppsala Monitoring Centre, and a former North America... Read More →
avatar for Jordi Llinares Garcia

Jordi Llinares Garcia

Head of Product Development Scientific Support Department, European Medicines Agency, European Union
Jordi Llinares is a medical doctor specialised in clinical pharmacology. He worked as clinical pharmacologist at Hospital de Sant Pau and has experience as member of an ethics committee. Jordi has academic experience as lecturer in clinical pharmacology. He has a Masters degree in epidemiology. He joined the EMA in 2002 as a scientific officer working for orphan drugs. He became Head of Section of Orphan Medicines in 2009 and in 2013 Head of... 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. She has authored numerous articles. May 2013. she received the AAP’s Excellence in Public Service Award & in 2014 FDA's Dr. Francis Kelsey Award.
avatar for Lynne Yao

Lynne Yao

Director, Division of Pediatric and Maternal Health, FDA
Lynne Yao, MD, is the Director, Office of New Drugs, Division of Pediatric and Maternal Health in the Center for Drug Evaluation and Research, US Food and Drug Administration. The Division of Pediatric and Maternal Health oversees quality initiatives within the Office of New Drugs that promote and necessitate the study of drug and biological products in the pediatric population and improve pregnancy and lactation-related information in product... Read More →


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