Certificate of Advanced Studies CAS

Regulatory Affairs in Life Science

Berner Fachhochschule BFH
Biel/Bienne Jardin Paradis (BE)
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Program overview

  • Type of course
    Berufsorientierte Weiterbildung, Universities of Applied Sciences
  • Degree
    Certificate of Advanced Studies CAS Certificate of Advanced Studies (CAS) in «Regulatory Affairs in Life Sciences»
  • Course language
    Englisch
  • Time commitment
    Alongside employment
  • Duration

    Week 43 to week 14
    Friday: 1pm to 7.30pm

What the program looks like

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. The programme comprises the following modules: Overview Regulations, Regulatory requirements for medical devices in the USA, Quality and risk management,Product Engineering,vValidation and Operation, Digitalization and cybersecurity in life sciences and Semester project (Living Case).

Admission

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 engineering, medical technology, or medical informatics, in medicine/veterinary medicine, in pharmacy or in life sciences. 

Costs

CHF 7'850.-

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