Regulatory Affairs

Regulatory Affairs is the discipline of applying regulations and standards in the development, approval and marketing of medicinal products and medical devices with the aim of ensuring the safety and efficacy of these products. This programme will provide you with the necessary expertise to work as a Regulatory Affairs Professional in the highly regulated environment of the medical technology, pharmaceutical and biotech industries.

The program

  • is aimed 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 the industry.
  • consists of 4 CAS modules and the master’s thesis and usually takes 2.5 to 3 years.
  • is taught in English.
  • has national and international participants.

Factsheet

  • Degree/Certificate Master of Advanced Studies (MAS)
  • Duration 5 semesters
  • Schedule Various implementation dates
  • Application deadline One month before the start of the study
  • ECTS credits 60 ECTS-Credits
  • Costs CHF 30’400
  • Teaching language English
  • Location Biel, Aarbergstrasse 46
  • School School of Engineering and Computer Science
  • Next session Spring semester 2023
    Autumn semester 2023

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:

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

Objectives

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 MAS Regulatory Affairs is structured as follows:

Mandatory modules

Elective modules

In addition, elective modules can be completed from a wide range of all offers. The elective modules are listed in the «Masterplan Weiterbildungsangebote und Module (PDF, 772 KB)»

Master’s thesis

The Master’s thesis serves to methodically deepen and practically implement learning content acquired during the program, with a focus on a university-oriented, scientific approach. The total time required to complete the master’s thesis usually extends over the last module and the semester of implementation and comprises a workload of 12 ECTS (360 hours).

  • Preparation: During the last module, the topic is defined, and the proposal/disposition is prepared.
  • Implementation: Independent development of the master’s thesis with two reviews, submission of the report and defense.
  • Direct instruction
  • Self-study
  • Research project work
  • Master’s thesis

Title + Degree

Master of Advanced Studies (MAS) in Regulatory Affairs

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.

Study Guidance