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Continuing Education Credits are not available for the archived offering.
This archive may be purchased through October 13, 2015.
Archive duration: 1 hour 31 minutes

Series Overview
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 1: Overall Challenge: The Vision of Better Medicines for Children Overview

Drug development is a complex process that calls for the balancing of the requirements of a number of viewpoints and interests, including those of the pharmaceutical industry, regulatory authorities, science, ethics, politics and, not least, the patient. Over the last few decades, the demand for a stronger focus on drug treatment in children has developed from the voices of just a few pediatricians into action by governments and regulatory authorities.

Over the past 50 years, the view has evolved from protecting children from research to protecting children through research. The critical need for pediatric research on drugs and biological products reinforces the responsibility to assure that children are only enrolled in research that is both scientifically necessary and ethically sound.

Part I of the webinar series will provide an overview of the framework of the vision of pediatric drug development and the vision of better medicines for children.  The discussion will start with the beginning of modern drug development, the introduction of modern labels in the 1960s, and the ensuing beginning of off-label treatment of most children. Also discussed will be the advances of medical treatment of adults and children and reflect the vision of better medicines for children, which evolved during a time period when medical treatment of children had never been better in human history, but was still perceived as something where further room for improvement was left. Key leading experts from pharmaceutical industry, regulatory authorities and clinical academia will give their respective viewpoints.

Other Webinars in this Series:

Part 2:  Regulatory Framework
Part 3:  Regulatory Framework EU
Part 4:  Dosing in Children
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

Learning objectives

At the conclusion of this webinar, participants should be able to:

  • Discuss the history and framework of pediatric drug development
  • Describe the advances in medical treatment of adults and children and reflect the vision of better medicines for children

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Archived Webinar
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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.