Continuing Education Credits are not available for the archived offering.
This archive may be purchased through October 13, 2015.
Archive duration: 1 hour 22 minutes
Knowledge of new medicines for children and clinical research has increased over the past decades. A revolution has taken place in pediatric oncology, where new dosing and new combinations of anticancer drugs developed for adult cancer have made the diagnosis of child cancer no longer an automatic death sentence.
DIA is presenting a Seven-Part webinar series on Pediatric Drug Development, which will start with an overview of the challenges and historical background of pediatric drug development, then proceed to specific discussion of US and EU pediatric legislation, and, in four additional pivotal webinars, discuss technical specificities of dosing in children, particular requirements in pediatric clinical trials, the development of pediatric formulations, and the need and challenges of juvenile animal studies.
Part 4: Dosing in Children Overview
One of the key challenges of drug treatment in children is the definition of adequate doses. A science has evolved that tries to predict the appropriate dose in children through modeling and simulation. A further challenge is that phase I studies in healthy children are not allowed. So, before dose proposals for use in children can be made, organizations need to go through an elaborate program and discuss it upfront with the regulatory authorities. This webinar will discuss technical specificities of dosing in children.
Other Webinars in this Series:
Part 1: Overall Challenge: The Vision of Better Medicines for Children
Part 2: Regulatory Framework
Part 3: Regulatory Framework EU
Part 5: Technical Development: Pediatric Formulations
Part 6: Preclinical Toxicology & Safety
Part 7: Operational Challenges of Pediatric Clinical Trials
Who should attend?
Scientific staff in industry working on pediatric drug development within the field of:
- Clinical Development, Clinical Pharmacology and Formulation Development
- Regulatory Agency Staff and Industry Regulatory Affairs
- Clinical Investigators Involved in Pediatric Studies
At the conclusion of this webinar, participants should be able to:
- Discuss the science of pediatric dosing
- Identify the challenges in establishing adequate dosing for pediatric patients
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No refunds will be provided in the event of a participant’s cancellation since all costs for this webinar have been prepaid by DIA. DIA reserves the right to modify or cancel programs and/or substitute presenters or panelists. DIA is not responsible for failure to deliver programs due to circumstances beyond its control.
Participants with Disabilities: Reasonable accommodations will be made available to persons with disabilities who attend an educational activity. Contact the DIA office in writing at least 15 days prior to event to indicate your needs.