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Monday, June 25 • 11:00am - 12:15pm
#119: ‘Target’ing Pediatric Oncology Development: New Global Pediatric Considerations Under FDARA 2017

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-531-L04-P; CME 1.25; IACET 1.25; RN 1.25

The new requirements in FDARA Title V will substantially impact the conduct of pediatric oncology research globally. This session will explore the pediatric provisions in FDARA Title V, assess feasibility challenges in pediatric oncology drug development, and how they may be impacted by the new provisions in law, and will assess the potential global impact of FDARA. Session will include an interactive, global Q&A session with the audience and panel.

Learning Objectives

Describe and explain the new provisions in FDARA 2017 Title V that will impact global pediatric oncology development going forward; Analyze the implications and assess the impact of these new provisions on global pediatric oncology development.


Melodi J McNeil


Industry Perspective
Christina Bucci-Rechtweg, MD

FDA Perspective
Lynne P. Yao, MD

EMA Perspective
Agnès Saint-Raymond, MD

avatar for Christina Bucci-Rechtweg

Christina Bucci-Rechtweg

Global Head, Maternal Health and Pediatric Regulatory Policy, Novartis Pharmaceuticals Corporation, 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 →
avatar for Melodi McNeil

Melodi McNeil

Director, Regulatory Policy and Intelligence, AbbVie, Inc., United States
Melodi J. McNeil, R.Ph., M.S. Ms. McNeil is currently a Director in AbbVie’s Rockville, Maryland Regulatory Policy and Intelligence office. She identifies, assesses, and comments on proposed regulatory policies, and ensures appropriate AbbVie personnel are aware of emerging and... Read More →
avatar for Agnès Saint-Raymond

Agnès Saint-Raymond

Head of Division International Affairs, European Medicines Agency, Netherlands
Agnes is an MD and qualified French Paediatrician. She worked as a paediatrician in a paediatric Hospital in Paris, France, then in pharmaceutical industry, and then moved to the French Medicines Agency. In 2000 she joined the European Medicines Agency (EMA) and was responsible for... 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 →

Monday June 25, 2018 11:00am - 12:15pm EDT
Room 204AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  09: Regulatory, Session