CRED Understanding Clinical Development 2024

08/10/2024

Paediatric Investigation Plans

Steve Pinder PhD, Envestia Ltd

The Organisation for Professionals in Regulatory Affairs The Organisation for

Professionals i Regulatory Affairs

1

Learning outcomes

Legal framework

•

Why children are different

•

• Preferred approaches to clinical development in children

Devising PIP strategy

•

• Content and format of a PIP

PIP review process

•

Compliance checking

•

The Organisation for Professionals in Regulatory Affairs

2

1