Short course Management of Clinical Trials – Medical Devices 2025
Micro-credential
This Micro-credential Short Course Medical Devices corresponds to module 11 of the DAS in Management of Clinical Trials.
Information
Period
18 March 2025 - 19 March 20251 ECTS credits (micro-credential)
16 Teaching hours
Personal working hours: 14
EQF-level
7Language
EnglishFormat
On-siteRegistration
Registration deadline
18 February 2025Fees:
CHF 1,400
Contribution to the SDGs
Objectives
- Understand the regulatory and legal aspects of new Swiss and EU regulations governing medical devices, including Swiss Federal Medical Ordinance (MDO), Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), including certifications and submissions to competent bodies and authorities.
- Learn about the qualification and classification of medical devices under the new regulations.
- Gain knowledge of clinical investigation requirements and the process of submitting clinical trial applications to regulatory authorities.
- Develop strategies for market access, including navigating regulatory pathways and obtaining necessary approvals.
- Familiarise with conformity assessment procedures and the CE marking process for medical devices.
- Understand the principles and practices of materiovigilance for monitoring and reporting adverse events related to medical devices.
- Explore the role of digital health and medical software in the context of medical device regulation.
- Learn about combination products and the regulatory considerations involved in their development and approval.
Audience
Professionals involved in the development, regulation, and market access of medical devices, including regulatory affairs specialists, product managers, quality assurance professionals, and individuals responsible for ensuring compliance with medical device regulations.
Learning outcomes
- Ability to interpret and apply EU regulations (MDR, IVDR) to medical device development and management.
- Ability to classify medical devices according to regulatory requirements.
- Competence in planning and conducting clinical investigations and preparing clinical trial applications for regulatory submission.
- Skill in developing market access strategies and obtaining regulatory approvals for medical devices.
- Proficiency in conducting conformity assessments and ensuring compliance with CE marking requirements.
- Understanding of materiovigilance principles and practices for ensuring the safety of medical devices.
- Knowledge of digital health technologies and their regulatory implications in the medical device industry.
- Ability to navigate regulatory requirements for combination products and ensure compliance throughout the development process.
Director(s)
Prof. Youssef DAALI and Prof. François CURTIN, Faculty of Science and Faculty of Medicine, University of Geneva
Coordinator(s)
Prof. François CURTIN, Dr Catherine SUAREZ and Ms Camille ARNI, University of Geneva
Accreditation
The course is accredited by Swissethics, Swiss Association of Pharmaceutical Professionals (SwAPP), Swiss Society of Clinical Pharmacology and Toxicology (SGKPT-SSPTC), Swiss Institute for postgraduate and continuous medical education (SWIF-ISFM).
Presentation Module 11 DAS - Mariagrazia Di Marco & Gabriel Avigdor
Assessment
Multiple Choice Questions (MCQ)
Admission criteria
a) Holders of a university master's degree or doctorate in science, medicine or pharmacy or a qualification deemed equivalent;
or a bachelor's degree in nursing from a Swiss University of Applied Sciences;
or a qualification deemed equivalent or professional experience deemed equivalent by the programme directors.
b) Good oral and written comprehension of English (equivalent to level B2-C1)
Steering committee
- Prof. Gerrit BORCHARD, President of the Section of Pharmaceutical Sciences (ISPSO), Faculty of Science, University of Geneva
- Prof. Alexandra CALMY, Vice-Dean of clinical research, Director of the Clinical Research Centre (CRC), Head of HIV/AIDS Unit, Associate Physician, Department of Infectious Diseases, Geneva University Hospitals
- Prof. Youssef DAALI, Head of the Pharmacological Investigation Unit, Geneva University Hospitals, Faculty of Medicine, University of Geneva
- Prof. Antoine GEISSBUHLER, Dean of the Faculty of Medicine, University of Geneva
- Dr Olivier HUBER, President, Cantonal Commission on Human Research Ethics, Canton of Geneva
- Prof. Samia HURST, Director, Institute of Ethics, History and Humanities (iEH2), Faculty of Medicine, University of Geneva
- Prof. Arnaud PERRIER, Medical Director, Geneva University Hospitals
Scientific committee
- Dr Emilie ALIROL, Senior Director Clinical Affairs, FIND
- Dr Enrica ALTERI, Pharmaceutical consultant, former Head of Human Medicine R&D Support Division, EMA
- Prof. Francois CURTIN, Medical Director Personalised Health Programmes, Swiss Federal Institute of Technology in Zürich & Lecturer at Geneva University Hospitals, University of Geneva
- Prof. Youssef DAALI, Head of the Pharmacological Investigation Unit, Geneva University Hospitals, Faculty of Medicine, University of Geneva
- Dr Patricia DELAITE, Chief Medical Officer, Nouscom, Basel
- Dr Catherine DELOCHE, Chief Operating Officer, Solid Drug Development, Geneva
- Prof. Jules DESMEULES, Faculty of Medicine, University of Geneva
- Prof. Philippe DUCOR, Faculty of Law, University of Geneva
- Prof. Marc FROISSART, Full Professor Clinical Research, Faculty of Biology & Medicine - FBM, UNIL, Lausanne
- Prof. Angèle GAYET-AGERON, Head of the Methodological Support Unit, Clinical Research Centre (CRC), Geneva University Hospitals, Faculty of Medecine, University of Geneva
- Prof. Angela HUTTNER, Associate Professor, Department of Infectious Diseases, Geneva University Hospitals, Faculty of Medicine, University of Geneva
- Dr Cyril JAKSIC, Statistician, Methodological Support Unit, Clinical Research Centre (CRC), Geneva University Hospitals
- Dr Françoise LASCOMBES, External Consultant
- Dr Guillaume PERRIARD, PhD, Lead patient Engagement, Novartis, Basel
- Dr Victoria ROLLASON, Division of Clinical Pharmacology and Toxicology, Geneva University Hospitals and Faculty of Medicine, University of Geneva
Application File
- Copy of identity document
- Passport photo (jpg format following these guidelines here)
- Curriculum Vitae
- Copies of relevant university degrees
- Covering letter
- Dr Mariagrazia DI MARCO
- Me Gabriel AVIGDOR
Contribution to the SDGs
Related programmes
- DAS - Management of Clinical Trials (2024)
- Session - Management of Clinical Trials – Ethical and Legal Aspects (2024)
- Session - Management of Clinical Trials – Clinical Trials Set-up and Conduct (2025)
- Session - Management of Clinical Trials – Clinical Trials Conduct and Close-out (2025)
- Session - Management of Clinical Trials – Audits and Inspections (2025)