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54877-01 - Lecture: Regulatory Affairs and its Applications (2 CP)
| Semester | spring semester 2023 |
| 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 |
| Comments | Dates: 24.02 - Med-tech Start Up, IP Thematik 24.03 - Quality management, Risk management, QMS ISO 13485 End March/Begin April Med tech Regulatory Affairs CH, EU, International Mid/Late April - Med tech Regulatory Affairs CH, EU, International 23.05 - IP Strategy for high-tech startups May - Medical Applications and Medical Software |
| 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 |
|---|---|---|---|
| unregelmässig | See individual dates | ||
Dates
| Date | Time | Room |
|---|---|---|
| Friday 24.02.2023 | 13.15-17.00 | Hegenheimermattweg 167B, Lecture Hall 02. 097 |
| Friday 24.03.2023 | 13.15-17.00 | Hegenheimermattweg 167B, Lecture Hall 02. 097 |
| Friday 31.03.2023 | 13.15-17.00 | Hegenheimermattweg 167B, Lecture Hall 02. 097 |
| Friday 28.04.2023 | 13.15-17.00 | Hegenheimermattweg 167B, Lecture Hall 02. 097 |
| Friday 05.05.2023 | 13.15-17.00 | Hegenheimermattweg 167B, Lecture Hall 02. 097 |
| Tuesday 23.05.2023 | 13.15-17.00 | --, -- |
| 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: 19.06.2023, 14:00 - 16:00, Pharmacenter Hörsaal 1 |
| 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) |