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54877-01 - Lecture: Regulatory Affairs and its Applications (2 CP)
| Semester | spring semester 2022 |
| Course frequency | Every spring sem. |
| Lecturers |
Philippe Claude Cattin (philippe.cattin@unibas.ch, Assessor)
Rolf Kaufmann (ROLF.KAUFMANN@UNIBAS.CH) Nila-Pia Rähle (nilapia.raehle@unibas.ch) Jan Stifter (jan.stifter@unibas.ch) Pascal Wettmann (pascal.wettmann@unibas.ch) |
| Content | - Med Tech Start Up, Technology Management, Company Structure, - Med tech Regulatory Affairs (Swissmedic,EMA,FDA), Notified Bodies, - Intellectual Property, Licences, Patents - Medical Software and Applications |
| Admission requirements | Limited number of students only, priority will be given to students the Master in Biomedical Engineering. |
| Language of instruction | English |
| Use of digital media | No specific media used |
| Interval | Weekday | Time | Room |
|---|---|---|---|
| 14-täglich | Friday | 13.15-17.00 | Gewerbestrasse 14 |
Dates
| Date | Time | Room |
|---|---|---|
| Friday 25.02.2022 | 13.15-17.00 | Gewerbestrasse 14, Vorlesungsraum DBE 14.03.002 |
| Friday 04.03.2022 | 13.15-17.00 | Gewerbestrasse 14, Vorlesungsraum DBE 14.03.002 |
| Friday 01.04.2022 | 13.15-17.00 | Gewerbestrasse 14, Vorlesungsraum DBE 14.03.002 |
| Friday 22.04.2022 | 13.15-17.00 | Gewerbestrasse 14, Vorlesungsraum DBE 14.03.002 |
| Thursday 12.05.2022 | 13.15-17.00 | --, -- |
| Friday 13.05.2022 | 13.15-17.00 | Gewerbestrasse 14, Vorlesungsraum DBE 14.03.002 |
| Friday 10.06.2022 | 14.00-16.00 | Pharmazentrum Hörsaal 1, -- |
| Modules |
Module: Biomaterials Science and Nanotechnology (Master's Studies: Biomedical Engineering) Module: Image-Guided Therapy (Master's Studies: Biomedical Engineering) |
| Assessment format | record of achievement |
| Assessment details | Multiple Choice Exam |
| Assessment registration/deregistration | Reg.: course registration, dereg: cancel course registration |
| Repeat examination | one repetition, best attempt counts |
| Scale | 1-6 0,5 |
| Repeated registration | as often as necessary |
| Responsible faculty | Faculty of Medicine |
| Offered by | Departement Biomedical Engineering (DBE) |