Spring Intro 2023
03/03/2023
The (clinical) assessor
• Not necessary a physician • Pharmacologist, pharmacists, molecular biologist, statisticians etc. • Assessing is team work • We think, not doing anything
3 Understanding Clinical Development Program, March 2022
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How do we work (orientation)
• Within the legal environment • Try to learn as much as possible from the disease • interaction with the physician • interaction with patients
• Read the summary of the applicant • What scientific advises are provided • Search for comparable assessments
4 Understanding Clinical Development Program, March 2022
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