740866 VO Klinische Aspekte unerwünschter Arzneimittelwirkung
Sommersemester 2025 | Stand: 04.12.2024 | LV auf Merkliste setzen740866
VO Klinische Aspekte unerwünschter Arzneimittelwirkung
VO 1
2
Block
jährlich
Englisch
Monitoring safety; cellular toxicology (e.g. liver, long QT, hypersensitivity reactions), DSUR/PSURs/USM/clinical hold
- General considerations – Safety Population
- Epidemiology of Study population
- Safety Concern establishment/prediction of safety profile
- Reporting requirements, SUSARs, PADERs, DSURs
- Signal Detection Signal Detection activities and methods/Safety Science activities
- Urgent Safety Measures, temporary halt, early termination
- Specific Monitoring requirements, additional Risk minimization measures and populations not studied
- Risk management plan (RMP): concept, development and maintenance
- Self-centered learning content
Lecture with interactive elements involving student participation, audience response systems, online handouts
written exam
Modules 1 and 2
siehe Termine
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Gruppe 0
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| Datum | Uhrzeit | Ort | ||
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Mo 07.04.2025
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16.00 - 18.15 | online (Pharmazie) online (Pharmazie) | Kähler online | |
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Di 08.04.2025
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09.30 - 12.30 | online (Pharmazie) online (Pharmazie) | Kähler online | |
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Mi 09.04.2025
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09.30 - 12.30 | online (Pharmazie) online (Pharmazie) | Kähler online | |
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Fr 11.04.2025
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13.00 - 16.00 | L.03.112 L.03.112 | Kähler (Präsenz/online) | |
| Gruppe | Anmeldefrist | |
|---|---|---|
| 740866-0 | 01.02.2025 00:00 - 21.02.2025 23:59 | |
| Kähler S. | ||