Navigating Pediatric Regulations in the United States and European Union

Description

The FDA and EMA’s requirement of pediatric plans for new active ingredients, dosage forms, dosing regimens or routes of administration has made a thorough understanding of such regulations essential. In fact, without a Paediatric Investigational Plan, the EMA will no longer validate any submission.

INC Research is dedicated to helping companies navigate this challenging environment efficiently – so much so that we’re holding a free webinar on the topic during which Klaus Rose and William Sietsema will share their advice on how to create insightful and innovative pediatric strategies that meet these stringent regulatory requirements.

This webinar is part of a series on Pediatric Clinical Trials

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