Short course Management of Clinical Trials 鈥� Ethical and Legal Aspects 2024
Micro-credential
This Micro-credential Short Course聽Ethical and Legal Aspects corresponds to module 3 of the DAS in Management of Clinical Trials.
Information
Period
14 October 2024 - 16 October 20242 ECTS credits (micro-credential)
24 Teaching hours
Personal working hours: 36
EQF-level
Language
EnglishFormat
On-siteRegistration
Registration deadline
14 September 2024Fees:
CHF 1,800
Contribution to the SDGs
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.
Director(s)
Prof. Youssef DAALI and Prof. Fran莽ois CURTIN, Faculty of Science and Faculty of Medicine, AV短视频
Coordinator(s)
Prof. Fran莽ois CURTIN, Dr Catherine SUAREZ and Ms Camille ARNI, AV短视频
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).
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 AV短视频 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, AV短视频
- 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 AV短视频 Hospitals
- Prof. Youssef DAALI, Head of the Pharmacological Investigation Unit, Geneva AV短视频 Hospitals, Faculty of Medicine, AV短视频
- Prof. Antoine GEISSBUHLER, Dean of the Faculty of Medicine, AV短视频
- Dr聽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, AV短视频
- Prof. Arnaud PERRIER, Medical Director, Geneva AV短视频 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 Z眉rich & Lecturer at Geneva AV短视频 Hospitals, AV短视频
- Prof. Youssef DAALI, Head of the Pharmacological Investigation Unit, Geneva AV短视频 Hospitals, Faculty of Medicine, AV短视频
- Dr Patricia DELAITE, Chief Medical Officer, Nouscom, Basel
- Dr Catherine DELOCHE, Chief Operating Officer, Solid Drug Development, Geneva
- Prof. Jules DESMEULES, Faculty of Medicine, AV短视频
- Prof. Philippe DUCOR, Faculty of Law, AV短视频
- Prof. Marc FROISSART, Full Professor Clinical Research, Faculty of Biology & Medicine - FBM, UNIL, Lausanne
- Prof. Ang猫le GAYET-AGERON, Head of the Methodological Support Unit, Clinical Research Centre (CRC), Geneva AV短视频 Hospitals, Faculty of Medecine, AV短视频
- Prof. Angela HUTTNER, Associate Professor, Department of Infectious Diseases, Geneva AV短视频 Hospitals, Faculty of Medicine, AV短视频
- Dr Cyril JAKSIC, Statistician, Methodological Support Unit, Clinical Research Centre (CRC), Geneva AV短视频 Hospitals
- Dr Fran莽oise LASCOMBES, External Consultant
- Dr Guillaume PERRIARD, PhD, Lead patient Engagement, Novartis, Basel
- Dr Victoria ROLLASON, Division of Clinical Pharmacology and Toxicology, Geneva AV短视频 Hospitals and Faculty of Medicine, AV短视频
Application File
- Copy of identity document
- Passport photo (jpg format following these guidelines )
- Curriculum Vitae
- Copies of relevant university degrees
- Covering letter
- Prof. Samia HURST
- Dr Emilie ALIROL
- Dr Brigitte HAPP
Contribution to the SDGs
Related programmes
- DAS - Management of Clinical Trials (2024)
- Session - Management of Clinical Trials 鈥� Clinical Trials Set-up and Conduct (2025)
- Session - Management of Clinical Trials 鈥� Clinical Trials Conduct and Close-out (2025)
- Session - Management of Clinical Trials 鈥� Medical Devices (2025)
- Session - Management of Clinical Trials 鈥� Audits and Inspections (2025)