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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)

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