Module 1 2021

01/07/2021

Timelines PIP procedure

Day -30 Applicantio n

2 nd discussion PDCO Day 60

1st discussion PDCO Day 30

Day 61 Update Sum Report

Adoption of Opinion

Stop Clock

~ 3 mont hs

Day 1 After Validation, Sum Report

3 rd discussion PDCO Day 90

OE

Adoption of Opinion, OR List of Issues

OE= oral explanation

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Content of PIP Paediatric Investigation Plan

• Basis for development and authorisation of a medicinal product for all paediatric population subsets • Discussion whether or not the product could cover an unmet medical need in children; • Discussion on similarity of disease and mode of action within and between subgroups (adults and children of different ages); • Is extrapolation of efficacy data possible? • Which patients groups (different ages, different disease stages) need to be studied?; • Includes details of the timing and the measures proposed to demonstrate: • Quality; • Safety; • Efficacy; What is needed for a MA- Benefit-risk balance? • Position of modelling and simulation within the benefit-risk assessment?

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