Transcription
MAS / DASMedical Device RegulatoryAffairs and Quality Assurance
Advanced Studies inMedical Device RegulatoryAffairs and Quality Assurancesitem-insel School, Center for Translational Medicine and BiomedicalEntrepreneurship, Faculty of Medicine, University of BernObjectivesRegulatory specialists are integral to bringing novel medical devices to market.They require a breadth of managerial and interpersonal skills in addition totechnical, clinical and legal knowledge. The program of Advanced Studies inMedical Device Regulatory Affairs (RA) and Quality Assurance offers careerspecialised training for graduate students based on the newly implementedEuropean Medical Device Regulations (MDR). In addition, the course providesparticipants with comprehensive knowledge and practical experience in: international RA, quality management, risk management, clinical evaluation of medicaldevices, technical writing and leadership.ParticipantsThe program addresses university graduates interested in commencing a career inthe regulation or quality control of medical devices. The program prepares students to work regulatory officers or quality managers within a medical devicecompany or regulatory body. The program also targets those from complementarydisciplines such as entrepreneurship, research and development, and management,seeking comprehensive and practical knowledge of the regulation of medicaldevices according to the new European MDR.FacultyThe faculty is comprised of leading experts from industry and academics, andincludes specialists from regulatory agencies with extensive international experience in the regulation and quality assurance of medical technologies.2MAS / DAS in Medical Device Regulatory Affairs and Quality Assurance
The DegreesStudents can undertake the program as a Master of Advanced Studies (MAS) or aDiploma of advanced studies (DAS). MAS in Medical Device Regulatory Affairs and Quality Assurance:A minimum of 60 ECTS over a course duration of 24 months. Students complete Modules 1 – 9 and two elective modules chosen from modules 10 – 12.The course includes an non-compulsary industry based learning componentduring which the MAS thesis can be completed. DAS in Medical Device Regulatory Affairs and Quality Assurance:A minimum of 37 ECTS over a minimum course duration of 14 months.Students complete Modules 1 – 6 and one elective module chosen fromModules 7 – 9 in addition to the DAS thesis.Degrees are awarded by the University of Bern upon successful completion of theprogram. Programs are undertaken on a part time basis.Study Program and Learning EnvironmentThe program is taught in a blended learning environment, allowing for flexibleeducation that complements part time professional work. The courses utilisee-learning, peer learning and interactive discussions with experts, on site lectures,workshops and case studies. The MAS program additionally includes an optionalindustry based learning placement in the second year of study. Class sizes arelimited to ensure high quality personal education that fosters communication andprofessional networking.3
Program StructureAdvanced Studies10 ECTSMAS60 ECTSCore Studies30 ECTSElective Studies4 ECTSIndustry based LearningMAS Thesis16 ECTSAdvanced Studies3 ECTSDAS37 ECTSCore Studies30 ECTSDAS Thesis4 ECTSYear 1Year 2Core StudiesM1 Research and Development Processes (2 ECTS)Module 1 provides an overview of medical device research, development andverification processes in order to provide understanding of the regulatory environment.M2 EU Medical Device Regulations Part A (6 ECTS)Module 2 introduces the regulatory landscape and the European Medical DeviceRegulations (MDR). It focusses on the structure, interpretation and application ofthe MDR and includes a complex study of medical device classification.M3 EU Medical Device Regulations Part B (6 ECTS)Module 3 focusses on the interpretation and practical application of the generalsafety and performance requirements and technical documentation requirementsas outlined in the MDR.M4 EU Medical Device Regulations Part C (6 ECTS)Module 4 is comprised of three submodules covering the regulation of labellingand instructions for use, conformity assessment and product registration, and postmarket surveillance and post market clinical follow-up.M5 Quality Management (5 ECTS)Module 5 provides a comprehensive and practical study of quality assurance as itpertains to medical devices.4MAS / DAS in Medical Device Regulatory Affairs and Quality Assurance
M6 Risk Management and Usability Engineering (5 ECTS)Module 6 teaches the purpose, methodology and regulation of medical device riskidentification, assessment and mitigation. The module includes a comprehensivestudy of usability regulation, assessment and risk assessment.Advanced StudiesM7 Clinical Evaluation for Medical Devices (4 ECTS)Module 7 concentrates on the clinical evaluation required to demonstrate thedevice’s intended purpose without exposing users and patients to unnecessary risk.The module covers the collection and reporting of pre- and post-market clinicaldata including safety reporting.M8 Digitalisation, Software and Cybersecurity (3 ECTS)Module 8 focuses on the regulatory framework for medical device software. Itprovides an overview of the software development lifecycle and the managementof software quality. The module additionally covers cybersecurity and the regulation of devices based on artificial intelligence.M9 International Regulatory Affairs (3 ECTS)Module 9 provides an overview of international regulatory affairs with a particularfocus on the US and Asian medical device regulations and path to market.Elective StudiesM10 Combination Products (3 ECTS)Combination products include a combination of a medical device, and/or drugand/or biologic. Module 10 will cover the corresponding regulatory requirementsfor each component, their similarities and differences. The market launch of acombination product on the market will be discussed.M11 Market Access and Pricing (2 ECTS)Module 11 introduces the complementary topics of health economics & outcomesresearch, pricing & reimbursement and health policy including health technologyevaluation. In a case study, the optimal price level for a product as well as a launchsequence to optimise profitability will be developed.M12 Leadership, Team and Project Management for Regulatory Experts(2 ECTS)Regulatory and quality experts inhabit critical roles that rely on successful intraand inter-department communication, the management and motivation of teamsand the management of tasks and projects. Module 12 aims to provide studentswith the skills and confidence to work successfully within a regulatory team andwithin a regulatory managerial position.5
Additional InformationLocationOn-sight classes are held at sitem-insel, the Swiss Institute for Translational andEntrepreneurial Medicine in Bern, Switzerland. If required, classes can be joinedremotely. E-learning activities may be performed at home or on site at sitem-inselwhere students have access to facilities of the sitem-insel school. In case ofuniversity closure due to covide 19, all classes will be provided online.Industry Based LearningThe MAS program includes an optional industry placement within a professionalmedical device regulatory environment in the second year of the program. Studentshave the option of completing their MAS thesis during the placement and coursework will complement the placement.Admission RequirementsApplicants must hold a Bachelor degree or higher degree in engineering, computer science, pharmacy, life sciences, health management, medicine, law or otherrelevant scientific discipline. No professional experience is required.EnrolmentParticipants will be enrolled at the University of Bern. Upon successful registration,participants will receive a campus account. MAS students will receive a UNICARDand have access to university services, sports, childcare and counselling facilitiesoffered by the University of Bern.LanguageThe course language is English.6MAS / DAS in Medical Device Regulatory Affairs and Quality Assurance
Start and DurationThe program will commence on September 1st, 2020 and is designed to run for aminimum of 2 semesters (DAS) or 4 Semesters (MAS). The MAS course duration is24 months. The DAS can be completed in a minimum of 14 months with durationdependent on the chosen elective Module.FeesThe fee for the MAS in Medical Device Regulatory Affairs and Quality Assurance isCHF 31’500.- and for the DAS program CHF 23’100.-.The sitem-insel SchoolThe School for Translational Medicine and Biomedical Entrepreneurship (sitem-insel School) is jointly run by the University of Bern, sitem Center for TranslationalMedicine and Biomedical Entrepreneurship and the Swiss Institute for Translationaland Entrepreneurial Medicine in Bern (sitem-insel AG).Contact and RegistrationMail: school@sitem.unibe.chPhone: 41 31 664 6400Website: www.sitem-insel.ch/schoolApplication deadline: 16.08.2020Online Application: www.sitem-insel.ch/MDRQFurther InformationFor further questions about the study program in Medical Device RegulatoryAffairs and Quality Assurance, please contact:Prof. Dr. Juergen Burger, Director School(juergen.burger@med.unibe.ch)Dr. Kate Gerber, Program Coordinator(kate.gerber@sitem.unibe.ch)7
sitem-insel Schoolsitem-insel AGsitem-insel SchoolFreiburgstrasse 33010 BernSwitzerland 41 31 664 ity of BernFaculty of Medicinesitem Center for Translational Medicineand Biomedical EntrepreneurshipFreiburgstrasse 33010 chPartnersInselspitalUniversity Hospital Bernwww.insel.chHSeTwww.hset.org
The fee for the MAS in Medical Device Regulatory Affairs and Quality Assurance is CHF 31’500.- and for the DAS program CHF 23’100.-. The sitem-insel School The School for Translational Medicine and Biomedical Entrepreneurship (sitem-in-sel
