740867 SE Klinisches Prüfpräperat (Investigational Medicinal Product, IMP) - Dossier
Sommersemester 2023 | Stand: 20.04.2023 | LV auf Merkliste setzen740867
SE Klinisches Prüfpräperat (Investigational Medicinal Product, IMP) - Dossier
SE 1
1
Block
jährlich
Englisch
• Students should understand the content and structure of an IMPD and its role in the development process
• They should be capable of placing information in the relevant sections
Structure and content for the information on quality, safety and pharmacology of a new drug
• Structure of the IMPD
• IMPD content reflecting the developmental stage
• From IMPD to Marketing Authorization Dossier Module 3
• Current requirements according to the CTR (CTIS)
• Practical example of writing an IMPD
Seminar mit Anwendung des Erlernten auf spezifische Fragestellungen durch die Studierenden.
Modules 1 and 2
25.04.2023
Mi 03.05.2023, 13:45-16:15 Uhr, CCB, 3. Stock, L.03.112
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Gruppe 0
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| Datum | Uhrzeit | Ort | ||
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Di 25.04.2023
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13.45 - 16.15 | online (Pharmazie) online (Pharmazie) | ||
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Mi 26.04.2023
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13.45 - 16.15 | online (Pharmazie) online (Pharmazie) | ||
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Do 27.04.2023
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13.45 - 14.45 | online (Pharmazie) online (Pharmazie) | ||
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Do 27.04.2023
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15.00 - 16.00 | L.03.121 L.03.121 | ||
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Di 02.05.2023
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13.45 - 16.15 | L.03.121 L.03.121 | ||