323114 VU The path from bench to bedside - a regulatory view - MPS5 (2025S)
Prüfungsimmanente Lehrveranstaltung
Labels
An/Abmeldung
Hinweis: Ihr Anmeldezeitpunkt innerhalb der Frist hat keine Auswirkungen auf die Platzvergabe (kein "first come, first served").
- Anmeldung von Mo 10.02.2025 08:00 bis Mo 19.05.2025 20:00
- Abmeldung bis Mo 19.05.2025 20:00
Details
Sprache: Englisch
Lehrende
Termine (iCal) - nächster Termin ist mit N markiert
continuous document preparation in groups at home required
- Montag 26.05. 16:45 - 18:15 Digital
- Montag 02.06. 16:45 - 17:30 Digital
- Dienstag 10.06. 16:45 - 17:30 Digital
- Montag 16.06. 16:45 - 17:30 Digital
- Freitag 20.06. 16:45 - 17:30 Digital
Information
Ziele, Inhalte und Methode der Lehrveranstaltung
The course will be held in english and will performed in an online modeThis course will give an overview on the regulatory process for the transformation process from compound to pharmaceutical drugs in Europe (FDA approval is not part). The differences for Investigational New Drugs (INDs) and New Drug Applications (NDAs), as well as diagnostics and therapeutics will be discussed including the requirements for Good Clinical Practice (GCP). A focus will be placed on the requirements for the drug-related documentation, the Investigational Medicinal Product Dossier (IMPD).Based on the acquired knowledge a short IMPD will be prepared for a pharmaceutical drug. The IMPDs will be rated in a peer-reviewed process by the students. Finally, the revised IMPD will be presented in the auditorium.The lecture will be in english and in an online setting, preparation of on IMPD and working in a team required
Art der Leistungskontrolle und erlaubte Hilfsmittel
1. Attendance & Participation: participants are expected to attend all course sessions and actively participate in the course.
2. Oral presentations and written exercises to be handed in as outlined during the course.
2. Oral presentations and written exercises to be handed in as outlined during the course.
Mindestanforderungen und Beurteilungsmaßstab
1. Class attendance
2. Active participation in class and with team.
3. Written short IB or IMPD for a pharmaceutical drug.
4. Presentation of the IB or IMPDs
2. Active participation in class and with team.
3. Written short IB or IMPD for a pharmaceutical drug.
4. Presentation of the IB or IMPDs
Prüfungsstoff
Literatur
Zuordnung im Vorlesungsverzeichnis
Letzte Änderung: Mo 28.04.2025 14:06