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RE: Conducting Pediatric Studies in Ex-US Countries

Talking about EU countries, it depends on age group and the disease. If the course of the disease is similar in adults and older teenagers (16 - 18) will eventually get the same dose as adults in normal clinical practice, it may be feasible although the PIP (Pediatric Investigational Plan) will...



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Conducting Pediatric Studies in Ex-US Countries

Are there any challenges in identifying countries outside of the US that will allow #pediatric trials in their country if the Sponsor has no plans to seek marketing authorization for the pediatric population in their country? #ClinicalResearch #Pediatric #RegulatoryAffairs -- Kathryn Fransen...