Module 1 2021

01/07/2021

All EMA Scientific Committees are involved with paediatric medicines):

• CHMP; Authorizes medicines for paediatric (and adult) use • PRAC; Monitors safety of paediatric (and adult) authorised medicines • CAT; Assesses advanced therapies for children (and adults) • COMP; Designates medicinal products as orphan drugs, for paediatric (and adult) use • HMPC; Discusses herbal medicinal products for paediatric (and adult) use • SAWP; Provides SA for paediatric studies • PDCO; Agrees Paediatric Investigation Plans, Waivers, modifications of plans, checks compliance with plans, advises other committees/ EC on paediatric use

The Organisation for Professionals in Regulatory Affairs

11

Life cycle medicine:

The Organisation for Professionals in Regulatory Affairs

12

6