Micro-credential
This Micro-credential Short Course Ethical and Regulatory Aspects corresponds to module 3 of the DAS in Management of Clinical Trials and MAS Drug Discovery and Clinical Development.
Overview
Objectives
- Understand the principles of Human Subject research ethics.
- Demonstrate knowledge of the informed consent process.
- Recognise the importance of data protection and confidentiality in clinical studies.
- Explain the purpose and function of Research Ethics Committees (EC).
- Evaluate risks and benefits associated with research participation.
- Identify and address ethical considerations for vulnerable populations in clinical trials.
- Apply principles of Good Clinical Practice (GCP) in clinical trial management.
- Familiarise with the legal frameworks governing Human Subject Research, including interventional studies with investigational medicinal products and medical devices, in Switzerland, Europe, and the United States.
- Familiarise ethical issues related to biobanks in clinical research.
Audience
Healthcare professionals, researchers, and individuals involved in Human Subject Research, including clinical trial managers, coordinators, monitors, scientists, and regulatory affairs specialists.
Learning outcomes
- Ethical decision-making in clinical research and clinical trial management.
- Compliance with regulatory requirements and Good Clinical Practice standards.
- Effective communication with stakeholders regarding ethical considerations.
- Understanding of regulatory framework and processes.
- Critical thinking and problem-solving in addressing ethical dilemmas in biobanking and clinical research.
Registration
Registration deadline
22 September 2025
Fees:
CHF 1,800
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)
Application File
- Copy of identity document
- Curriculum Vitae
- Copies of relevant university degrees
- Covering letter
Curriculum
Period
13 October 2025 - 15 October 2025
Teaching hours
24 teaching hours
Microcertification
2 ECTS credits
EQF-level: 7
Assessment
Multiple Choice Questions (MCQ)
Intervenant-es
- Prof. Samia HURST
- Dr Emilie ALIROL
- Dr Brigitte HAPP
Partnerships / Collaboration
Accreditation / Recognition / Certification
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).
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
Steering committee
- Prof. Gerrit BORCHARD, President of the Section of Pharmaceutical Sciences (ISPOS), 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, Dept 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 Samia HURST, Director, Institute of Ethics, History and Humanities (iEH2), Faculty of Medicine, University of Geneva
- Dr Pierre-Yves MARTIN, President, Catonal Commission on Human Research Ethics, Canton of Geneva
- Prof Klara POSFAY BARBE, 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, Head of the Centre for Clinical Research, Lucerne Cantonal Hospital (LUKS), 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 Catherine DELOCHE, Chief Operating Officer, Solid Drug Development,Geneva
- Prof Jules DESMEULES, Faculty of Medicine, University of Geneva
- Prof Marc FROISSART, Chief Medical Director of the Clinical Research (CRC), CHUV-UNIL, Lausanne
- Dr Angèle GAYET-AGERON, Full Professor in Epidemiology and Public Health & Director of the Institute of Social and Preventive Medicine (ISPM) at University of Bern
- Dr Brigitte HAPP, External Consultant
- 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, PharmD, Division of Clinical Pharmacology and Toxicology, University Hospitals of Geneva and Faculty of Medicine, University of Geneva
Related programmes
- MAS - Drug Discovery and Clinical Development (2025)
- DAS - Management of Clinical Trials (2025)
- Session - Management of Clinical Trials – Medical Statistical and Trial Methodologies (2025)
- Session - Management of Clinical Trials – Clinical Trials Set-up and Conduct (2026)
- Session - Management of Clinical Trials – Clinical Trial Conduct and Close-out (2026)
- Session - Management of Clinical Trials – Audits and Inspections (2026)
- Session - Management of Clinical Trials – Regulatory Strategy and Procedures in Product Development (2026)
- Session - Management of Clinical Trials – Medical Devices (2026)
Contribution to the Sustainable Development Goals
