Regulatory Affairs in Life Science
CAS
Berner Fachhochschule BFH
- Ausbildungsort
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Biel/Bienne (BE)
- Unterrichtssprache
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Englisch
- Ausbildungstyp
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Weiterbildung: Lehrgänge - Fachhochschulen FH
- Zeitliche Beanspruchung
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Teilzeit
- Ausbildungsthemen
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Elektronik, Mikrotechnik
- Studienrichtungen
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Biomedizinische Wissenschaften und Technologie - Medizintechnik
- Swissdoc
-
7.555.33.0
Aktualisiert 28.08.2024
Beschreibung
Beschreibung des Angebots
Certificate of Advanced Studies is a postgraduate qualification awarded by universities and corresponds to at least 10 ECTS (credit points).
Products from the life sciences industry are subject to strict national and international laws and standards. The CAS Regulatory Affairs in Life Sciences focuses on the regulations concerning medical devices, in vitro diagnostics, and medical software. Experienced experts will guide you through the practice-oriented course content and equip you with the necessary knowledge to navigate the regulated environment of the life sciences industry.
Aufbau der Ausbildung
- Overview Regulations
- Quality and Risk Management
- Product Engineering
- Validation and Operation
- Statistics
- Semester work (Living Cases)
Voraussetzungen
Zulassung
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, students 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.
Target audience
Participants:
- are planning to work in a regulated environment in the medical device- or in the life sciences industry.
- are currently working in the areas of development, manufacturing, quality management or regulatory affairs.
- are responsible for the early detection and analysis of risks in the areas of medical technology, medical informatics or in the life sciences industry.
Link zur Zulassung
Anmeldung
See the provider's website. Registration takes place online.
Kosten
CHF 7'500.-
Abschluss
- Certificate of Advanced Studies CAS
Certificate of Advanced Studies (CAS) in «Regulatory Affairs in Life Sciences»
Praktische Hinweise
Ort / Adresse
- Biel/Bienne (BE)
Berner Fachhochschule
Aarbergstrasse 46
2503 Biel
Zeitlicher Ablauf
Beginn
Autumn
Dauer
Week 43 to week 14
Zeitliche Beanspruchung
- Teilzeit
Unterrichtssprache
- Englisch
Links
Auskünfte / Kontakt
Berner Fachhochschule Technik und Informatik
Weiterbildung
Tel. +41 (0)31 848 31 11
E-Mail: office.ti-be@bfh.ch
Anbieter 1
Berner Fachhochschule BFH
Falkenplatz 24
3012 Bern
Tel.: +41 (0)31 848 33 00
E-Mail:
URL:
www.bfh.ch/de/
Weitere Informationen
Departement Technik und Informatik TI
Berner Fachhochschule BFH
Quellgasse 21
2501 Biel/Bienne
Tel.: +41 (0)32 321 61 11
E-Mail:
URL:
www.bfh.ch/ti/de/