Micro-credential
This Micro-credential Short Course Ethical and Regulatory Aspects corresponds to module 3 of the DAS in Management of Clinical Trials.
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
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
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 AV¶ÌÊÓÆµ 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
Teaching hours
Microcertification
Assessment
Intervenant-es
- Prof. Samia HURST
- Dr Emilie ALIROL
- Dr Brigitte HAPP
Partnerships / Collaboration
Accreditation / Recognition / Certification
Director(s)
Prof. Youssef DAALI and Prof. François CURTIN, Faculty of Science and Faculty of Medicine, AV¶ÌÊÓÆµ
Coordinator(s)
Steering committee
- Prof. , President of the Section of Pharmaceutical Sciences (ISPOS), Faculty of Science, AV¶ÌÊÓÆµ
- 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 AV¶ÌÊÓÆµ Hospitals
- Prof Youssef DAALI, Head of the Pharmacological Investigation Unit, Geneva AV¶ÌÊÓÆµ Hospitals, Faculty of Medicine, AV¶ÌÊÓÆµ
- Prof , Director, Institute of Ethics, History and Humanities (iEH2), Faculty of Medicine, AV¶ÌÊÓÆµ
- Dr , President, Catonal Commission on Human Research Ethics, Canton of Geneva
- Prof Klara POSFAY BARBE, Medical Director, Geneva AV¶ÌÊÓÆµ Hospitals
Scientific committee
- ¶Ù°ùÌý, Senior Director Clinical Affairs, FIND
- Dr , Pharmaceutical consultant, former Head of Human Medicine R&D Support Division EMA
- ±Ê°ù´Ç´Ú.Ìý, Head of the Centre for Clinical Research, Lucerne Cantonal Hospital (LUKS), Lecturer at Geneva AV¶ÌÊÓÆµ Hospitals, AV¶ÌÊÓÆµ
- Prof Youssef DAALI, Head of the Pharmacological Investigation Unit. Geneva AV¶ÌÊÓÆµ Hospitals, Faculty of Medicine, AV¶ÌÊÓÆµ
- ¶Ù°ùÌý, Chief Operating Officer, Solid Drug Development,Geneva
- Prof Jules DESMEULES, Faculty of Medicine, AV¶ÌÊÓÆµ
- Prof , Chief Medical Director of the Clinical Research (CRC), CHUV-UNIL, Lausanne
- Dr , Full Professor in Epidemiology and Public Health & Director of the Institute of Social and Preventive Medicine (ISPM) at AV¶ÌÊÓÆµ of Bern
- Dr , External Consultant
- Dr , Statistician, Methodological Support unit, Clinical Research Centre (CRC), Geneva AV¶ÌÊÓÆµ Hospitals
- Dr , External Consultant
- Dr , PhD, Lead Patient Engagement, Novartis, Basel
- ¶Ù°ùÌý, PharmD, Division of Clinical Pharmacology and Toxicology, AV¶ÌÊÓÆµ Hospitals of Geneva and Faculty of Medicine, AV¶ÌÊÓÆµ
Related programmes
- DAS - Management of Clinical Trials (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 – Medical Devices (2026)
- Session - Management of Clinical Trials – Audits and Inspections (2026)