EMA perspective on the value of model‐informed drug development for labeling recommendations regarding medicine use during pregnancy and breastfeeding

• Efthymios Manolis,
• Flora Tshinanu Musuamba,
• Corinne S. deVries,
• Pieter J. Colin,
• Martin B. Oleksiewicz

Affiliations

Efthymios Manolis

European Medicines Agency Amsterdam The Netherlands

Flora Tshinanu Musuamba

Federal Agency for Medicines and Health Products Brussel Belgium

Corinne S. deVries

European Medicines Agency Amsterdam The Netherlands

Pieter J. Colin

European Medicines Agency Amsterdam The Netherlands

Martin B. Oleksiewicz

Danish Medicines Agency Copenhagen Denmark