A Regulatory & Strategic Framework for Facilitating Pediatric Drug Development

Описание: 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 provide an overview of the global regulatory framework and requirements that drive pediatric development. They 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 share with you how to effectively communicate the plan to regulatory authorities.

Certara accelerates medicines to patients using proprietary biosimulation software and technology to transform traditional drug discovery and development. Its clients include 1,600 global biopharmaceutical companies, leading academic institutions, and key regulatory agencies across 60 countries.

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