Spring Intro 2023

16/02/2023

We have covered

• 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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Today’s main messages

• Success requires a positive benefit-risk profile

• TPP • Carefully constructed CDP

Know what you are aiming at

•

• You are responsible for the regulatory aspects (acceptability of the CDP to regulatory authorities) • To be really effective, you need a good working knowledge of clinical drug development, medical statistics and the relevant medicine

• Regulatory input to clinical development

• If you don’t, nobody else will • A missing PIP (or waiver) will prevent MAA validation

• Check whether a PIP is needed for all projects

The Organisation for Professionals in Regulatory Affairs

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