DIA 2017 Annual Meeting

Component Type: Session
Level: Intermediate
CE: ACPE 1.50 Knowledge UAN: 0286-0000-17-564-L04-P; CME 1.50; IACET 1.50; RN 1.50

The availability of safe, effective therapies is critical to meet the needs of pediatric patients. FDA’s 2016 status report on the BPCA and PREA concluded that progress has been made in obtaining pediatric studies and new labeling but significant challenges remain in studies for neonate, infants, pediatric cancer, and international coordination of pediatric trials.

This DIAmond panel will discuss recent progress in global pediatric research and regulatory science and new developments in pediatric research networks such as the Pediatric Trials Consortium (C-Path Institute) and the International Neonatal Consortium.

Learning Objectives

Discuss recent legislative and regulatory developments in the US and EU related to pediatric studies and labeling and their expected impact on availability of safe and effective therapies for children; Identify regulatory and research approaches to address challenges that limit the availability of innovative medicines for infants, neonates, and children.

Chair

Ronald Portman, MD

Speaker

Panelist
Susan McCune, MD

Panelist
Mark Turner

Panelist
Robert M. Ward, MD

Panelist
Christoph Male, MD

Panelist
Marie-Helene Pinheiro, PharmD