Short course Management of Clinical Trials – Clinical Trials Set-up and Conduct 2025
Micro-credential
This Micro-credential Short Course Clinical Trials Set-up and Conduct corresponds to module 7 of the DAS in Management of Clinical Trials.
Information
Period
20 January 2025 - 22 January 20252 ECTS credits (micro-credential)
24 Teaching hours
Personal working hours: 36
EQF-level
7Language
EnglishFormat
On-site – switch over to online-learning if requiredRegistration
Registration deadline
20 December 2024Fees:
CHF 1,800
Contribution to the SDGs
Objectives
- Understand scientific, strategic, and safety considerations in clinical trial design.
- Develop budgets and plan resources effectively for clinical trials.
- Select appropriate investigator sites for trial implementation.
- Identify the role of Contract Research Organisations (CROs) and external providers in clinical trial management.
- Familiarise with essential clinical trial documents and their significance in trial conduct.
- Navigate the submission process to Swiss Ethics Committees (EC) and Regulatory Authorities (RA).
- Implement risk management strategies to ensure trial safety and compliance.
Audience
Professionals involved in clinical trial management, including clinical research coordinators, project managers, regulatory affairs specialists, and individuals responsible for trial set-up and conduct.
Learning outcomes
- Proficiency in designing clinical trials considering scientific, strategic, and safety aspects.
- Ability to develop and manage budgets for clinical trial operations.
- Skill in selecting investigator sites based on strategic criteria and operational feasibility.
- Understanding of the roles and responsibilities of CROs and external providers in clinical trial management.
- Competence in preparing and managing essential clinical trial documents.
- Proficiency in navigating the submission process to Swiss Ethics Committees and Regulatory Authorities.
- Ability to implement risk management strategies to mitigate potential risks during trial conduct.
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).
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 Shelly BUSTION
- Dr Sandrine CHARVAT
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 Conduct and Close-out (2025)
- Session - Management of Clinical Trials – Medical Devices (2025)
- Session - Management of Clinical Trials – Audits and Inspections (2025)