Spring Intro 2023

03/03/2023

How do we work (introduction)

Working top down

Select the correct template Copy and paste the content from the applicant’s overview Delete the opinion of the applicant

If necessary add structure to the assessment

Assesses the robustness of the studies Assess the measure of the effect and its clinical relevance Assess the safety

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How we work (the Thinking)

Discuss the results with the team

Show stoppers for methodology, PK or tox. Missing information When possible obtain an expert opinion

Assess benefits compared to risks in light of the indication Add additional information to the assessment Benefit risk assessment Formulate an advise for CHMP/CMDh/national authority

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