Program Overview

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Introduction to the CAS in Regulatory Affairs Program

The CAS in Regulatory Affairs program is designed for regulatory specialists who require a breadth of managerial and interpersonal skills, in addition to technical, clinical, and legal knowledge. This program offers career-specialized training in Regulatory Affairs, Quality Management, and Advanced Regulatory Affairs, with a particular focus on the European Medical Device Regulations.

Program Details

• Degree: Certificate of Advanced Studies in Regulatory Affairs, Universität Bern (CAS RA Unibe)
• Start: 2025
• Length: 2 semesters
• Scope: 15 ECTS
• Cycle: Annual
• Flexible entry possible: Yes
• Single module visitable: Yes
• Place: sitem-insel, Bern
• Language: English
• Admission: Minimum Bachelor's degree from a university or university of applied sciences in the fields of natural sciences, engineering, medicine, pharmacy, or law. Admission sur dossier is possible.
• Registration until: 2025/07/15
• Cost: CHF 12'600
• Special Offer: Upon request
• Organising institutions: School for Translational Medicine and Biomedical Entrepreneurship (sitem-insel School)

About the Program

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

What to Expect from this Program

• Increase your career prospects
• Obtain an internationally recognized 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

Who is the Program For?

The program addresses university graduates interested in commencing a career in regulatory affairs or quality management within a medical device company or regulatory body. It also targets mid-level experienced professionals who would like to raise their proficiency to the next level and approach different career options. Additionally, it 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.

Program Structure

The modular structure of the continuing education program in Regulatory Affairs and Quality Management allows you to pursue your goals tailored to your own needs. You can start with a Certificate of Advanced Studies (CAS) and gradually build it up to a Diploma or 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 you to profit from the lecturers' expertise.

Modules

Regulatory Affairs modules include:

• RA1: Introduction to Regulatory Affairs
• RA2: Pre-Submission Regulatory Affairs
• RA3: Post-Submission Regulatory Affairs

Organising Institution and Faculty

The Swiss Institute for Translational and Entrepreneurial Medicine (sitem-insel) is the organizing institution. It is located on the Insel Campus Bern and benefits from its proximity to Switzerland's largest university hospital (Inselspital) as well as the University of Bern. The Medical Faculty of the University of Bern offers education programs in translational medicine, biomedical entrepreneurship, regulatory affairs, and artificial intelligence.

Admission, Fees, and Installments

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, 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. Extensions of application deadlines may be granted by the Directorate. Once the application is received, it will be evaluated, and the applicant will be notified within a few working days.

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 Directorate 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.

Documents

• Study regulation RAQM (PDF, 226KB)
• Study Plan for the CAS Study Program in Regulatory Affairs (PDF, 129KB)
• Annexe (Module Table, Learning Objectives, and Content) (PDF, 241KB)
• Confidentiality Declaration (needed for Registration) (PDF, 56KB)

Associated Courses

CAS in Artificial Intelligence in Medical Imaging

• Degree: CAS
• Start: 2026
• Language: English
• Cost: CHF 10'080 This program offers a hands-on, application-focused introduction to Artificial Intelligence (AI) in the field of medical imaging.

CAS in Translational Medicine

• Degree: CAS
• Start: 2025
• Language: English
• Cost: CHF 12'600 The program includes all relevant aspects of the translational process, including basic scientific, clinical, and technical knowledge.

DAS in Translational Medicine

• Degree: DAS
• Start: 2025
• Language: English
• Cost: CHF 23'100 The program includes all relevant aspects of the translational process, entrepreneurial know-how, in addition to all basic scientific, clinical, and technical knowledge.

MAS in Translational Medicine and Biomedical Entrepreneurship

• Degree: MAS
• Start: 2026
• Language: English
• Cost: CHF 31'500 The program includes all relevant aspects of the translational process, entrepreneurial know-how, in addition to all basic scientific, clinical, and technical knowledge.