Program Overview

Program Overview

The Certificate of Advanced Studies in Advanced Regulatory Affairs (CAS ARA) is a comprehensive program that offers advanced knowledge in regulatory affairs for therapeutic products. The program is designed for individuals who wish to enhance their existing basic knowledge in European regulatory affairs and those from complementary disciplines such as entrepreneurship, research and development, and management.

Program Structure

The program is structured as a part-time, extra-occupational program that can be reconciled with professional work. The modular structure allows students to pursue their goals tailored to their own needs, starting with a Certificate of Advanced Studies (CAS) and gradually building up to a Diploma or Master of Advanced Studies in Regulatory Affairs and Quality Management (60 ECTS) degree over time.

Program Details

• The program starts in 2026 and has a duration of 2 semesters.
• The scope of the program is 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 taught in a blended learning environment, utilizing e-learning, peer learning, and interactive discussions with experts, on-site lectures, workshops, and case studies.
• Small class sizes allow for large flexibility while permitting students to profit from the lecturers' expertise.

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

• The admission process involves submitting a complete application, including all required attachments, via the registration form.
• Extensions of application deadlines may be granted by the Directorate.
• Upon successful registration, students will receive 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 e-journals.

Tuition Fees and Installments

• The tuition fee for the Certificate of Advanced Studies (CAS) is 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.).

Research Areas and Faculty

The program is offered by the School for Translational Medicine and Biomedical Entrepreneurship (sitem-insel School) and the Medical Faculty of the University of Bern. The faculty consists of senior experts from academia, industry, and regulatory authorities, who carry the teaching responsibility and support students in advancing their professional careers.

Organising Institutions and Faculty

• The Swiss Institute for Translational and Entrepreneurial Medicine (sitem-insel) is the organising institution, 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 an excellent curriculum in human and dental medicine and provides access to data science for all research groups.

Program Outcomes

The program aims to provide students with comprehensive knowledge and career-specialized training in regulatory affairs and quality management. Upon successful completion of the program, students will receive the degree Certificate of Advanced Studies in Advanced Regulatory Affairs from the University of Bern. The program is designed to increase career prospects, provide expert insights from academia and industry, and connect students with peers and lecturers in the field.