CRED Understanding Clinical Development 2024

08/10/2024

Why clinical data?

• Facilitate overall benefit-risk assessment

• Confirm efficacy, characterise safety

• Identify the target patient population(s)

• Provide data to support the SmPC

• Dose, regimen, contraindications, interactions

• Support post-authorisation activities

• Pricing & reimbursement, inclusion in formularies

Support promotional activities

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The Organisation for Professionals in Regulatory Affairs

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