Universität Wien

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

2.00 ECTS (1.00 SWS), SPL 32 - Pharmazie
Continuous assessment of course work
Moodle

Registration/Deregistration

Note: The time of your registration within the registration period has no effect on the allocation of places (no first come, first served).

Details

Language: English

Lecturers

Classes

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

Aims, contents and method of the course

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.

Assessment and permitted materials

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.

Minimum requirements and assessment criteria

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

Examination topics

Reading list

All required material is available at the moodle platform

Association in the course directory

Last modified: Tu 16.02.2021 10:30