Considerations On the Drug Development Process for Trials in Neonatology

Only available as part of a package

This module discusses why pediatric studies have failed, what could help improve success of pediatric trials, and explains why the Pediatric Research Equity Act (PREA) has not benefited neonates as much as the older pediatric population. The module provides examples of medication use with good intent that resulted in adverse outcomes to enhance understanding of why research is needed, and the unique considerations for studies that include neonates.

CE Credit Information:

Participants can earn .5 CE and .13 pharmacology credit for viewing the presentation and completing the evaluation.

The National Association of Neonatal Nurses is accredited as a provider of nursing continuing professional development by the American Nurses Credentialing Center’s Commission on Accreditation.

Sandra Sundquist Beauman, MSN, CNS, RNC-FDA

Sandra Sundquist Beauman is a manager of clinical trials operations at the University of New Mexico Health Sciences in Albuquerque, NM where she has been for the last 12 years. In this position, she is responsible for the regulatory and clinical management of neonatal and pediatric trials including assisting with development of protocols and associated documents for successful trial implementation. These trials include many NIH-sponsored trials through the Neonatal Research Network (NRN) and IdeA States Pediatric Clinical Trials Network (ISPCTN). Ms Beauman has a long career of clinical nursing in the Neonatal Intensive Care Unit (NICU) including Level 2 to Level 4 units in various states and holds certification in High-risk Neonatal Care. She began her nursing career with a diploma in 1980 and went on to advance her education through a Master’s in Nursing degree obtained in 1993. Ms Beauman was licensed and practiced as a Neonatal Clinical Nurse Specialist at various hospitals in California prior to her move to New Mexico.