Module232025

References

Some websites:

➢ https://www.fda.gov/ScienceResearch/SpecialTopics/P ediatricTherapeuticsResearch/default.htm ➢ https://www.fda.gov/Drugs/DevelopmentApprovalProc ess/DevelopmentResources/ucm049867.htm ➢ https://ec.europa.eu/health/human-use/paediatric medicines_en https://www.ema.europa.eu/en/human regulatory/overview/paediatric-medicines/paediatric regulation ➢ https://ec.europa.eu/health//sites/health/files/files/eu dralex/vol-1/reg_2006_1901/reg_2006_1901_en.pdf ➢

Nomenclature and Characterisation of the Active Ingredient

The Organisation for Professionals in Regulatory Affairs