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Activity Number: 45
Type: Contributed
Date/Time: Sunday, August 9, 2015 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract #316200 View Presentation
Title: Challenges on Pediatrics Clinical Trials
Author(s): Annpey Pong*
Companies:
Keywords: Pediatrics ; clinical trials ; FDA ; ICH ; EMEA ; T2DM
Abstract:

In recent years, the pediatrics clinical trials are increasing in the number of priority drugs that have labeling information for pediatric patients. However, different regions may have similar but different regulatory requirements for drug review and approval processes. In this presentation, the requirements from US Food and Drug Administration (FDA), European Medicine Agency (EMEA), and International Conference on Harmonization (ICH) are reviewed. Some practical issues and concerns in conducting the pediatrics clinical trials are discussed. In addition, an example of Type 2 Diabetes Mellitus (T2DM) in the pediatric population clinical trials is illustrated.


Authors who are presenting talks have a * after their name.

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