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Regulatory Affairs

The diploma will provide you with the expertise to work as a Regulatory Affairs Professional in a highly regulated environment.

The program

  • aims at people from the fields of pharmacy, medical technology, biotechnology, life sciences and law.
  • focuses on the regulation of pharmaceutical products and medical devices (incl. in-vitro diagnostics, combination products, software as a medical device).
  • is close to industry.
  • consists of 3 CAS modules
  • is taught in English.
  • has national and international participants.
  • can later be extended to a corresponding MAS degree.
DAS Regulatory Affairs

Factsheet

  • Degree/Certificate Diploma of Advanced Studies (DAS)
  • Duration 3 semesters
  • Application deadline 24 March
    23 September
  • ECTS credits 36 ECTS-Credits
  • Costs from CHF 22'500
  • Teaching language English
  • Location Biel, Aarbergstrasse 46 / Online
  • School School of Engineering and Computer Science
  • Next session Spring semester 2025
    Autumn semester 2025

Kontakt

DAS | Regulatory Affairs

Content + Structure

Portrait

The healthcare industry evolved greatly over the last 10 years. As a result, the tasks of Regulatory Affairs Professionals have changed accordingly. New technologies such as artificial intelligence and machine learning (e.g., decision support systems), home virus detection kits, wearable patient monitoring devices, companion diagnostics and precision medicine are already being used today. In the wake of such innovations and the resulting revision or creation of new regulations, Regulatory Affairs Professionals must continually expand their knowledge.

To obtain and maintain regulatory approval of healthcare products, Regulatory Affairs Professionals must fulfill the following core tasks:

  • Regulatory strategies
  • Implementing regulatory measures
  • Adhering to quality management
  • Solving trade-related issues
  • Negotiating/communicating with authorities
  • Crisis management

With the imparting of the above-mentioned expertise and the knowledge of the ever-changing regulations, the MAS Regulatory Affairs lays the foundation for entering the healthcare industry as a Regulatory Affairs Professional:

Developing regulatory strategies

  • Global regulatory strategies, e.g., ICH (International Harmonisation)
  • Structure and function of the relevant regulatory authorities

Implementing regulatory measures

  • EU Medical Device Regulation (MDR) and In-Vitro Diagnostic Medical Devices Regulation (IVDR)
  • Marketing authorisation, including the preparation of the scientific and technical dossier
  • Clinical evaluation
  • GxP
  • Market surveillance (pharmacovigilance/materiovigilance)
  • Knowledge of IT and data sciences
  • Product classes subject to special regulation (e.g. combination products or blood plasma)
  • Software as a Medical Device (SaMD)

Adhering to quality management

  • Quality management system according to ISO 13485 and ISO 9001
  • Pharmaceutical Quality System according to ICH Q10
  • Interfaces to processes such as risk management, usability engineering, reviews, design verification, design validation and process validation

Solving trade related issues

  • (Digital) supply chain management of medical and pharmaceutical products
  • Most important methods of traceability
  • Falsified products
  • Marketing and digital marketing

Negotiating/communication with authorities

  • Interaction with regulatory authorities, e.g. how meetings between applicant and regulatory authority are conducted

Crisis management

  • Leadership and management skills

Content

The DAS Regulatory Affairs is structured as follows:

  • Duration: 3 semesters
  • 3 CAS modules with 12 ECTS credits each

Mandatory modules

Elective modules

Title + Degree

Diploma of Advanced Studies (DAS) in Regulatory Affairs

Requirements + Admission

The programme is aimed at people from the fields of medical technology and computer science, pharmacy/chemistry, and life sciences as well as medicine or law who would like to work in the highly regulated environment of the medical technology, pharmaceutical and biotech industries or who would like to work as Regulatory Affairs Professionals in these areas.

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.

Legal foundations - Bern University of Applied Sciences

Infoevent and Study guidance

Contact

Fabienne Weiss

  • Wissenschaftliche Mitarbeiterin
  • +41 31 848 32 15
  • Show e-mail

Prof. Michael Lehmann

  • Leiter Medizininformatik
  • +41 32 321 64 36
  • Show e-mail

Study Guidance for Continuing Education

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 (Switzerland Innovation Park Biel/Bienne)

Biel, Aarbergstrasse 46

Bern University of Applied Sciences

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