Regulatory Affairs in Life Sciences

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.

This CAS:

  • 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).

Factsheet

  • Degree/Certificate Certificate of Advanced Studies (CAS)
  • Duration Week 43 to week 14
  • Schedule Friday: 1pm to 7.30pm
  • Application deadline 23 September
    8-24 participants
  • ECTS credits 12 ECTS-Credits
  • Costs CHF 7500
  • Teaching language English
  • Location Biel, Aarbergstrasse 46
  • School School of Engineering and Computer Science
  • Next session Autumn semester 2024

Structure + Content

Objectives + Skills

  • You gain comprehensive knowledge of the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) and demonstrate proficiency in their practical application.
  • You acquire the necessary expertise to establish a quality management system (QMS) for medical devices, aligning with ISO 13485.
  • You know the interfaces to processes such as risk management, usability engineering, reviews, design verification, design validation and process validations.
  • You develop the capability to implement national regulations pertaining to reporting obligations and corrective measures in the event of serious incidents involving medical devices.
  •  In a case study (semester work) you work on a real project or question from your company or from your own interest.
  • You are planning to work in a regulated environment in the medical device- or in the life sciences industry.
  • You are currently working in the areas of development, manufacturing, quality management or regulatory affairs.
  • You are responsible for the early detection and analysis of risks in the areas of medical technology, medical informatics or in the life sciences industry.

The individual modules that make up this programme are named below:

  • Overview Regulations
  • Quality and Risk Management
  • Product Engineering
  • Validation and Operation
  • Statistics
  • Semester work (Living Cases)
Skills profile CAS Regulatory Affairs Life Sciences Enlarge image

Bloom's taxonomy of learning objectives

  1. Knowledge: Reproduce what has been learned by heart.
  2. Comprehension: Explain, reformulate, or paraphrase what has been learned.
  3. Application: Apply what has been learned in a new context/situation.
  4. Analysis: Break down what has been learned into components, explain structures.
  5. Synthesis: Reassemble what has been learned or generate new content.
  6. Judgement: Critically evaluate what has been learned according to (mostly self-) chosen criteria.

A module may include a variety of teaching methods such as lectures, seminars, case studies, practical labs, assignments, etc.

For the 12 ECTS credits to be recognized, successful completion of the competency assessment is required (exam, semester work).

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.

Degree + Title

Certificate of Advanced Studies (CAS) in «Regulatory Affairs in Life Sciences»

Infoevent and Course guidance

Location

Classes are held at Aarbergstrasse 46 in the new building of the Switzerland Innovation Park Biel/Bienne (SIPBB), which is withing easy reach of Biel/Bienne railway station.

A location with many advantages

  • Classrooms within two minutes walking distance from Biel/Bienne railway station
  • Ideal train connections from Bern’s main railway station (every 15 minutes) and from Bern Wankdorf (every 30 minutes)
  • State-of-the-art infrastructure in the new SIPBB building
  • Various catering options in the immediate vicinity
  • Innovation and networking events

And that’s not all! Biel/Bienne is…

  • an innovation hotspot,
  • a university city,
  • an industrial and service city with numerous major players in the watchmaking, mechanical engineering, precision engineering and medical technology industries and major representatives of the communications and telecommunications sectors,
  • bordered by Lake Biel and its wide range of sports and leisure facilities,
  • a city that embodies bilingualism,
  • a town with a vibrant cultural life.

Biel, Aarbergstrasse 46

Bern University of Applied Sciences

Engineering and Computer Science
Switzerland Innovation Park Biel/Bienne
Aarbergstrasse 46
CH 2503 Biel