Spring Intro 2023

16/02/2023

TOPRA Introductory Course 2023

Clinical Drug Development, Paediatric Investigation Plans and the Link with Regulatory Affairs

Steve Pinder, Director

The Organisation for Professionals in Regulatory Affairs The Organisation for

Professionals i Regulatory Affairs

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We will cover

• Benefit-risk ratio

• Types of control in clinical trials

• Selection of endpoints

• Common study designs and their applications

• Role of regulatory professionals

• Paediatric investigation plans

The Organisation for Professionals in Regulatory Affairs

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