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Regulatory Examination of Nonclinical Testing Requirements and Juvenile Animal Studies
Session Chair(s)
David Jones, MS
Consultant, Regulatory Pharmaco-Toxicologist
ApconiX, United Kingdom
This symposium will examine the issues surrounding nonclinical testing requirements to support clinical trials in rare diseases, the importance and value of nonclinical juvenile animal studies for oncology products, as well as the role of juvenile animal studies in global pediatric product development. Juvenile animal studies can contribute significantly to risk assessment and safety in pediatric clinical trials and for drug product labeling, and their usefulness will be examined, primarily from a regulatory standpoint.
Learning Objective : Discuss the nonclinical requirements for clinical trials in rare diseases; Discuss the importance and value of nonclinical juvenile animal studies for oncology products; Identify recent regulatory guidance governing pediatric drug development and juvenile animal studies.
Speaker(s)
Nonclinical Requirements for Clinical Trials in Rare Diseases
David Jones, MS
ApconiX, United Kingdom
Consultant, Regulatory Pharmaco-Toxicologist
Nonclinical Support and the Role of Juvenile Animal Studies in Global Pediatric Product Development
Ikram Elayan, PhD
FDA, United States
Senior Pharmacology/Toxicology Reviewer, OND, CDER
Juvenile Animal Studies in Oncology Medicines for Children
Dinah Duarte, MSc
European Medicines Agency, Netherlands
Signal Management Lead