323114 VU The path from bench to bedside - a regulatory view - MPS5 (2026S)
Prüfungsimmanente Lehrveranstaltung
Labels
An/Abmeldung
Hinweis: Ihr Anmeldezeitpunkt innerhalb der Frist hat keine Auswirkungen auf die Platzvergabe (kein "first come, first served").
- Anmeldung von Mi 18.02.2026 08:00 bis So 03.05.2026 12:00
- Abmeldung bis So 03.05.2026 12:00
Details
Sprache: Englisch
Lehrende
Termine
Blocked VU, performed online, attendance mandatory
May 18, 16:30-18:00
May 26, 16:30-17:15
Jun 1, 16:30-17:15
Jun 8, 16:30-17:15
Jun 15, 16:30-17:15
Jun 22, 16:30-18:00
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
The course will be held in english
Literatur
Power Point and additional course material as provided via moodle
Zuordnung im Vorlesungsverzeichnis
Letzte Änderung: Mi 18.02.2026 07:47