Module 1 2021

01/07/2021

PDCO and procedures

The Organisation for Professionals in Regulatory Affairs

13

The EMA and its Paediatric committee (PDCO)

• EMA, European Medicines Agency; Staff (Scientific Administrators and Assistants) • PDCO, Paediatric Committee; • 1 member and 1 alternate from each EU member state; • 3 representatives and alternates for healthcare professions • 3 patient representatives and alternates • Monthly meetings • Procedures at PDCO • Evaluation team • 1 staff • 1 PDCO Rapporteur • 1 PDCO peer reviewer

The Organisation for Professionals in Regulatory Affairs

14

7