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Session Chair(s)
Gesine Bejeuhr, PHARMD
Pediatric Regulatory Leader
Bayer AG, Germany
Learning Objective : Discuss the paediatric information findings in medicinal products approved 5 years after the implementation of the Paediatric Regulation.Share the experience from paediatric European development process of medicines and discuss the necessity to increase global regulatory dialogue and communication
Speaker(s)
Pediatric information in medicines: Improving paediatric access to medicinal products?
Dinah Duarte, MSC
European Medicines Agency, Netherlands
Signal Management Lead
Paediatric Formulations - The EMA guideline
Diana Alexandra Van Riet, PHARMD, PHD
Medicines Evaluation Board (MEB), Netherlands
Senior Assessor
How do Companies Mangage These Challenges
Bettina Doepner, PHD, RAC
CSL Behring Innovation GmbH, Germany
Director Regulatory Science, Policy & Intelligence