Spring Intro 2023

03/03/2023

How we work (the result)

An assessment report contains

The factual presentation of the most important results Benefits and risks and the identified uncertainties Additional information to the assessment

An advise for CHMP/CMDh/national authority

7 Understanding Clinical Development Program, March 2022

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How we work (the aftermath)

Participate in the CHMP/CMDh/national authority meeting - for clarification only

Adapt the assessment report for finalisation

Inform the applicant

8 Understanding Clinical Development Program, March 2022

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