Swiss Institute for Translational and Entrepreneurial Medicine (sitem-insel)

Regulatory Affairs and Quality Management

Regulatory specialists are integral to bringing novel therapeutic products to market. They require a breadth of managerial and interpersonal skills in addition to technical, clinical and legal knowledge. The program of Advanced Studies in Regulatory Affairs and Quality Management (RAQM) offers comprehensive knowledge and career specialised training for graduate students.

What to expect from this program?

Increase your carreer prospects
Obtain an internationally recognised degree from a prestigious Swiss university
Gain expert insights from academia and industry
Connect and exchange with peers and lecturers
Acquire extensive knowledge and skills development in relevant topics
Keep up with the latest regulatory changes and implementations
Pursue a "Master of Advanced Studies" title in a stepwise approach
Profit from small class sizes and flexibility of study formats

Audience

Who is the program for?

The program addresses university graduates interested in commencing a career as a regulatory officer or quality manager within a medical device company or regulatory body. It also addresses mid-level experienced professionals who would like to raise their proficiency to the next level and approach different career options. Lastly, the program also targets those from complementary disciplines such as entrepreneurship, research and development, and management, seeking comprehensive and practical knowledge of the regulation of medical devices according to the new European MDR or quality management of such products.

Recent graduates will acquire comprehensive knowledge and skills, increase their career projects expand their personal network through close collaboration with peers and lecturers.

Learning objectives

Regulatory Affairs

to be familiar with the regulatory requirements, processes, and terms in all life cycle phases of a therapeutic product in the European market,
to be familiar with the regulatory environment and European legislation,
to be able to initiate and accompany the introduction and monitoring of a therapeutic product on the European market.

Quality Management

to be familiar with comprehensive quality management system concepts for the development, manufacture and distribution of therapeutic products,
to be able to apply the required quality, safety and efficacy standards in different life cycle phases of a therapeutic product,
to be familiar with basic principles and practices of risk management and can apply selected principles and methods of analysis.

Advanced Regulatory Affairs

To acquire comprehensive knowledge in three central and specialized areas of the regulation of therapeutic products.

Program structure

Design your own study journey

The modular structure of the continuing education program in Regulatory Affairs and Quality Mangement allows you to pursue your goals tailored to your own needs. You can start with a Certificate of Advanced Studies (CAS) in Regulatory Affairs, Quality Management or Advanced Regulatory Affairs and gradually build it up to a Master of Advanced Studies in Regulatory Affairs and Quality Management (60 ECTS) degree over time.

Scope

Each CAS corresponds to at least 15 ECTS credits, which are earned by completing at least three modules. One ECTS equals a study work performance of about 25-30 hours, including in-person events, preparatory tasks and all other course activities. The program is conceptualized as an extra-occupational program that can be reconciled with your professional work. The modules are taught in a blended learning environment and utilize e-learning, peer learning and interactive discussions with experts, on site lectures, workshops, and case studies. Small class sizes allow for large flexibility while at the same time permitting to profit from the lecturers’ expertise.

Postgraduate degree

After successful participations, the University of Bern awards the degree Master / Diploma / Certificate of Advanced Studies.

Study Programs

Admission & Fees

Admission requirements

Applicants must hold at least a Bachelor's degree from a university or university of applied sciences in the fields of natural sciences and engineering, medicine, pharmacy or law. Professional experience is not mandatory. If the applicant has no prior academic degree or professional experience, the study commission may define further conditions for the applicant to successfully complete the course.

Admission process

Please submit your complete application including all required attachments via the registration form. Extensions of application deadlines may be granted by the Directorate.
Once we have received your application, we will gladly evaluate your documents and get back to you within a few working days. Upon successful registration, you will get a Campus Account from the University of Bern, which allows access to the student area of the University websites, the University´s WLAN network (eduroam), the use of library databases and of e-journals. MAS students will also receive a UNICARD and have access to sports, childcare and counselling facilities offered by the University of Bern.

Deadlines

Application for fall term: 15th July
Application for spring term: 15th December
Standalone modules can be admitted anytime, provided places are still available.
The Directorat may grant exceptions on the above deadlines.

Tuition fees & installments

Master of Advanced Studies (MAS): CHF 31'500.–
Diploma of Advanced Studies (DAS): CHF 23'100.–
Certificate of Advanced Studies (CAS): CHF 12'600.–

The full study fee can be paid in full at once or in installments per semester.
There is no entitlement to a refund or waiver of the course fees if parts of the course are not attended. Costs for travel, accommodation and catering are not included. Insurance is in the sole responsibility of participants (accident, travel, cancellation, etc.).
Withdrawal of the registration before the registration deadline is possible without cost consequences. In case of withdrawal after the registration deadline, the full course fee must be paid.