CRED 8 Presentations

01/07/2024

Main tasks of the PDCO

• Assessing content of paediatric investigation plans (PIPs) and applications for full or partial waivers and deferrals;

• Assessing data generated in accordance with agreed PIPs;

• Adopting opinions on Q/S/E of a medicine for use in the paediatric population at request of CHMP or NCA;

• Advising MS on content and format of data to be collected through surveys on the uses of medicines in children;

• Advising and supporting the development of the European Network of Paediatric Research at the EMA;

• Providing advice on questions on paediatric medicines

• Establishing and updating an inventory of paediatric medicine needs

The Organisation for Professionals in Regulatory Affairs

27

27

Involvement of Scientific committees

T-36/48 MO

T-36/12 MO

T-24/12 MO

T-12 MO T 0

CHMP PRAC COMP PDCO SAGs WPs

CHMP PRAC SAWP

CHMP SAWP

CHMP PDCO

COMP PDCO

In addition, CAT involved in all steps for ATMPs

Launch

Pre-Submission phase

Post MA

Evaluation

28

The Organisation for Professionals in Regulatory Affairs

28