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CAS Regulatory Affairs in Life Sciences
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CAS Regulatory Affairs in Life Sciences
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Overview
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Week 43 to week 14
Duration
Biel, Aarbergstrasse 46 / Online
Location
12 ECTS
Credits
CHF 7'500
Cost
Registration deadline
23 September
Online
English
Language
Food service: Yes
Sports option: Yes
Certificate of Advanced Studies (CAS)
Degree type
Requirements
As a rule, a university degree and practical experience are required for admission.
People with a high vocational training can apply, provided they have suitable professional experience and prior scientific and methodological knowledge.
Ideally, you possess a degree in medicine, pharmacy, or a related scientific field. Additionally, qualifications in medical technology, medical informatics, engineering, legal studies, material science, or business administration, or a related discipline, would be highly advantageous.
More information
is directed towards individuals within the medical technology, medical informatics or pharmaceutical industry,
introduces you to the regulatory requirements of medical devices, in vitro diagnostics, and medical software (MDR, IVDR),
educates you on the product engineering processes within the medical industry and ensures your understanding of the legal and regulatory requirements governing design control,
introduces you to the definitions and classification of combination products,
provides you with the knowledge for qualification and classification of medical software (Software as a Medical Device, SaMD).
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