KEYNOTE:
“Research and Regulation”

Presenter:
Martin Offringa, M.D., Ph.D,
Professor and Head, Department of Pediatric Clinical Epidemiology; Staff member, Department of Neonatology, Emma Children's Hospital, Academic Medical Center, University of Amsterdam; Director, Netherlands Medicines for Children Research Network; Chair, International Forum for Standards for Research with Children www.STaRChildHealth.org; Co-Director, Dutch National Pediatric Pharmacotherapy Expertise Network, www.nkfk.nl; Co-Editor in chief, Evidence-Based Child Health: a Cochrane Review Journal, www.evidence-basedchildhealth.com

Abstract
Once a concept is developed to the point that testing can begin in human subjects, an Investigational New Drug (IND) application must be completed in the United States, with comparable applications required in other countries. Dr. Martin Offringa will discuss the application process and the role of a regulatory body. A discussion of the role of three regulatory agencies of different countries or unions will be presented.

Objectives
1. Discuss the role of regulatory bodies in drug/technology development
2. Define major areas of investigator failure and how to avoid them
3. Identify activities the investigator should know about from the beginning