Pediatric Clinical Trials Conference 2019

The Pediatric Clinical Trials Conference 2019 is dedicated to management tools, information and real life examples for pediatric research.

Topics

• Challenges of off label use in the pediatric population
• Unique challenges of conducting clinical trials in a pediatric setting
• Unique regulatory requirements for pediatric trials
• Consenting process in pediatric trials
• Key metrics and the factors that influence study complexity and workload
• The role and function of a data safety monitoring board in pediatric clinical trials
• Critical pathways in pediatric research program planning
• How to operationalize clinical research through program management
• Goals of the Global Pediatric Clinical Trials Network
• Challenges of pediatric research in different therapeutic areas
• The importance of self-monitoring
• How to effectively and efficiently prepare for monitoring and audit visits
• Approaches to recruitment in pediatric research
• Special considerations when developing budgets for pediatric research studies
• Challenges of long term follow up in pediatric clinical trials
• Strategies to retain pediatric participants
• The process of minimizing risk through good clinical practices
• When an IND or IDE application is required and expanded access regulations for pediatric research
• The process for identifying outcome measures in pediatric research studies

Who should Attend

Research professionals.