Micro-credential
This Micro-credential Short Course Clinical Trial Planning and Set-up corresponds to module 7 of the DAS in Management of Clinical Trials and MAS Drug Discovery and Clinical Development.
Overview
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.
Registration
Registration deadline
18 December 2026
Fees
CHF 1,800
- 3-day module: 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
18 - 20 January 2027
Teaching hours
24 teaching hours
Microcertification
2 ECTS credits
EQF-level: 7
Assessment
Multiple Choice Questions (MCQ)
Speakers
- Dr Erika CORREIA
- Dr Sandrine CHARVAT
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 and Dr Catherine SUAREZ, University of Geneva
Steering committee
- Prof Francesco GERVASIO, 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
- Mr Gilles AEBISCHER, Attorney-at-law, Head of Market Access & External Affairs Swiss Affiliate, OM Pharma
- Dr Emilie ALIROL, PhD, Public Private Partnerships, OM Pharma
- Dr Enrica ALTERI, MD, Pharmaceutical consultant, former Head of Human Medicine R&D Support Division EMA
- Prof François CURTIN, MD, Head of the Centre for Clinical Research, Lucerne Cantonal Hospital (LUKS) & Faculty of Medicine, University of Geneva
- Prof Youssef DAALI, PhD, Head of the Pharmacological Investigation Unit. Geneva University Hospitals, Faculty of Medicine, University of Geneva
- Dr Catherine DELOCHE, PhD, Chief Operating Officer, Solid Drug Development,Geneva
- Prof emerit. Jules DESMEULES, MD, Faculty of Medicine, University of Geneva
- Prof Marc FROISSART, MD , Department of Research and Education, CHUV-UNIL, Lausanne
- Dr Angèle GAYET-AGERON, MD, Full Professor in Epidemiology and Public Health & Director of the Institute of Social and Preventive Medicine (ISPM) at University of Bern
- Dr Brigitte HAPP, PhD, Regulatory Consultant, Happ-Consulting
- Dr Françoise LASCOMBES, MD, former Clinical Research Director, R&D, Sanofi, Paris
- Dr Guillaume PERRIARD, PhD, Medical Lead, Novartis, Basel
Related programmes
- MAS - Drug Discovery and Clinical Development (2025)
- DAS - Management of Clinical Trials (2026)
- Module - Management of Clinical Trials – Ethical and Regulatory Aspects (2026)
- Module - Management of Clinical Trials – Medical Statistical and Trial Methodologies (2025)
- Module - Management of Clinical Trials – Clinical Trial Conduct and Close-out (2027)
- Module - Management of Clinical Trials – Audits and Inspections (2027)
- Module - Management of Clinical Trials – Regulatory Strategy and Procedures in Product Development (2026)
- Module - Management of Clinical Trials – Medical Devices (2027)
- Module - Management of Clinical Trials – Medical Affairs Competency Framework – fundamentals (2026)
Contribution to the Sustainable Development Goals
