323114 VU The path from bench to bedside - a regulatory view - MPS5 (2025S)
Continuous assessment of course work
Labels
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).
- Registration is open from Mo 10.02.2025 08:00 to Mo 19.05.2025 20:00
- Deregistration possible until Mo 19.05.2025 20:00
Details
Language: English
Lecturers
Classes (iCal) - next class is marked with N
continuous document preparation in groups at home required
- N Monday 26.05. 16:45 - 18:15 Digital
- Monday 02.06. 16:45 - 17:30 Digital
- Tuesday 10.06. 16:45 - 17:30 Digital
- Monday 16.06. 16:45 - 17:30 Digital
- Friday 20.06. 16:45 - 17:30 Digital
Information
Aims, contents and method of the course
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
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.
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
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
Association in the course directory
Last modified: Mo 28.04.2025 14:06