740871 VO Arzneimittelsicherheit/Pharmakovigilanz
Sommersemester 2024 | Stand: 03.09.2024 | LV auf Merkliste setzenStudents understand post-marketing surveillance including pharmacovigilance
• Pharmacovigilance obligations post-marketing
• PBRER structure and development
• Post-Authorization studies: safety and efficacy studies,
• Medical Safety assessment, literature search, relevant databases (FAERS, EV, WHO),
• Case Management activities serious vs non-serious ICSR obligations,
• Risk management plan (RMP): concept, development and maintenance
• Risk Benefit Assessment in Pharmacovigilance and its impact on the active subsrance as well as class of compounds,
• Signal Detection activities and methods/Safety Science activitites,
• QPPV role and oversight, PMSF
• Pharmacoepidemiology and its relevance for benefit-risk assessments
Lecture with interactive elements involving student participation, audience response systems, online handouts
written exam
Modules 1 and 2
Gruppe 0
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Datum | Uhrzeit | Ort | ||
Di 21.05.2024
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09.30 - 10.45 | online (Pharmazie) online (Pharmazie) | verschoben von 04.06 auf 21.05.2024 | |
Do 23.05.2024
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09.30 - 11.15 | online (Pharmazie) online (Pharmazie) | verschoben von 06.06 auf 23.05.2024 | |
Mi 29.05.2024
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13.00 - 14.30 | online (Pharmazie) online (Pharmazie) | ||
Do 27.06.2024
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09.00 - 10.00 | Hörsaal 1, Josef-Moeller-Haus Hörsaal 1, Josef-Moeller-Haus | Barrierefrei | Prüfung |
Do 04.07.2024
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09.00 - 11.00 | L.03.121 L.03.121 | Prüfung | |
Mo 16.09.2024
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09.00 - 11.00 | L.03.121 L.03.121 | Sammelprüfung |
Gruppe | Anmeldefrist | Prüfungsdatum | |
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740871-0 | 11.07.2024 00:00 - 12.09.2024 23:59 |
16.09.2024
09.00 Uhr
L.03.121
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Hinweis: Falls jemand 2 od. mehrere Prüfungen am selben Tag hat, bitte um Angabe der Fächer, damit es zeitlich koordiniert werden kann. |
Kähler S. |