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54877-01 - Lecture: Regulatory Affairs and its Applications 2 CP

Semester spring semester 2020
Course frequency Every spring sem.
Lecturers Philippe Claude Cattin (philippe.cattin@unibas.ch, Assessor)
Nila-Pia Rähle (NILAPIA.RAEHLE@UNIBAS.CH)
Jan Stifter (jan.stifter@unibas.ch)
Content - Med Tech Start Up, Technology Management, Company Structure,
- Med tech Regulatory Affairs (Swissmedic,EMA,FDA), Notified Bodies,
- Intellectual Property, Licences, Patents

 

Language of instruction English
Use of digital media No specific media used

 

Interval every two weeks
Date 21.02.2020 – 15.06.2020
Time Friday, 13.15-17.00 Gewerbestrasse 14, Vorlesungsraum DBE 14.03.002

21.02.2020 Med-tech Start-up, IP
17.04.2020 Regulatory Affairs
24.04.2020 Quality management,
08.05.2020 Hands-on regulatory affairs
12.05.2020 IP Workshop
26.05.2020 Workshop Medical

Date Time Room
Friday 21.02.2020 13.30-15.15 Gewerbestrasse 14, Vorlesungsraum DBE 14.03.002
Friday 06.03.2020 13.15-17.00 Fasnachtsferien
Friday 17.04.2020 13.15-17.00 online via zoom
Friday 24.04.2020 13.15-17.00 online via zoom
Friday 08.05.2020 13.30-15.15 online via zoom
Tuesday 12.05.2020 13.00-18.00 --, --
Tuesday 26.05.2020 13.00-18.00 --, --
Monday 15.06.2020 10.00-12.00 Alte Universität, Hörsaal -101
Modules Module: Biomaterials Science and Nanotechnology (Master's Studies: Biomedical Engineering)
Module: Image-Guided Therapy (Master's Studies: Biomedical Engineering)
Assessment format proof of course participation
Assessment details Multiple Choice Exam
Assessment registration/deregistration Reg./dereg.: course registr./cancel registr. via MOnA
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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