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Sponsored Webcast: A Regulatory & Strategic Framework for Facilitating Pediatric Drug Development

September 22, 2022
On-Demand Webinar
YouTube video

Regulations in the US and Europe require and/or incentivize sponsors to evaluate their drugs (small molecules and biologics) for use in appropriate pediatric populations. It is generally agreed that that these regulations have stimulated new research efforts in pediatrics. It is essential that individuals, involved in global pharmaceutical research and development, are familiar with these regulations in order to create development efficiencies and minimize product development delays and cost.

During the webinar, pediatric development experts will provide an overview of the global regulatory framework and requirements that drive pediatric development. They will discuss intrinsic challenges with generating data across pediatric populations and provide case studies on how model-informed drug development (MIDD), can achieve a more efficient and more predictive clinical research process. Finally, our experts will share with you how to effectively communicate the plan to regulatory authorities.

Upon the conclusion of this webinar, you will:

  • Become aware of the global regulatory framework and the requirements that are driving pediatric development.
  • Become familiar with the principles of model informed drug development to enhance pediatric drug development.
  • Understand the principles for preparing a pediatric plan for submission to regulatory authorities.