Regulatory Considerations in Development of NEC Therapeutics
Regulatory Considerations in Development of NEC Therapeutics is organized by NICUniversity.
Date Released: Aug 11, 2017
Valid Until: This lecture does not expire.
HCPs in the field of Neonatology and other related professions.
Dr. Baer discusses the benefits of FDA approval for pediatric and neonatal therapeutics, including established effectiveness, pre- and post-marketing safety assessments, and defined clinically-meaningful endpoints. In the case of NEC, prevention of disease is a clinically-meaningful outcome. She also provides information on drug development tools that are relevant to NEC research, including clinical outcome assessments, biomarkers (e.g. for prediction of a patient’s risk), and animal models. Finally, potential clinical questionsare considered for the next phase of NEC research:
• What non-pharmacologic strategies for NEC prevention are most effective?
• Is there a clinical prediction strategy that can help define at-risk babies, either for non-pharmacologic prevention or pharmacologic prevention?
• What are the most effective treatment strategies for promoting long-term health?
• Review the current understanding of the pathogenesis, prevention and treatment of NEC.
• Establish a transdisciplinary collaboration of stakeholders to accelerate the implementation and standardization of established evidence based practices that can help to reduce the incidence and morbidity of NEC.
• Explore methods for empowering parents/families and supporting their engagement as part of their baby’s care team.
• Serve as a venue for researchers to create new collaborations and lines of investigation, including shared clinical databases and tissue banking.
Additional details will be posted as soon as information is available.
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