Universität Wien
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323114 VU The path from bench to bedside - a regulatory view - MPS5 (2021S)

2.00 ECTS (1.00 SWS), SPL 32 - Pharmazie
Prüfungsimmanente Lehrveranstaltung
Moodle

An/Abmeldung

Hinweis: Ihr Anmeldezeitpunkt innerhalb der Frist hat keine Auswirkungen auf die Platzvergabe (kein "first come, first served").

Details

Sprache: Englisch

Lehrende

Termine

03. May 9-12 am
10. May 9-10 am
17. May
24. May 9-10 am
31. May
7. June 9-10 am
14. June
21 June 9-11 am (end presentation)

Information

Ziele, Inhalte und Methode der Lehrveranstaltung

This 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.

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.

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

Prüfungsstoff

Literatur

All required material is available at the moodle platform

Zuordnung im Vorlesungsverzeichnis

Letzte Änderung: Di 16.02.2021 10:30