DAS Management of Clinical Trials 2025
Join Our Online Information Session for 2025-26!
Interested in our DAS or MAS programmes? Join us for a live Zoom session to learn more, ask questions, and meet us!
Join Our Online Q/A session for 2025-2026:
Date: Monday, 5 May 2025
Time: 10AM -11 AM (CET)
Location: Online on
Information
Period
September 2025 - June 202733 ECTS credits
169 Teaching hours
276 hours of personal work; 540 hours of personal work for the DAS Thesis.
Language
EnglishFormat
On-siteRegistration
Registration deadline
15 June 2025Modules can be followed individually
Fees:
CHF 9鈥�000.- for the Diploma
1-day module: CHF 1,000
2-day module: CHF 1,400
3-day module: CHF 1,800
For the whole DAS, we offer the flexibility of installment payments upon request (initial payment before the end of August).
Contribution to the SDGs
Objectives
- Provide essential knowledge and understanding of drug development and marketing authorization processes
- Enable participants to understand issues related to human subject research
- Describe the different clinical trial designs and methodologies
- Give a theoretical and practical insight on project planning and management in clinical trials
- Provide effective tools to comply with clinical research regulations and Good Clinical Practices (GCP)
- Enable participants to successfully manage trial applications to ethics committees and regulatory authorities
- Illustrate how to implement quality systems in clinical trials
Audience
Medical doctors, biologists, pharmacists, veterinarians, nurses, biochemists and other professionals involved, or wishing to gain skills and knowledge, in the field of clinical research
Learning outcomes
- Understand and use in a relevant context the different Clinical Trial designs and methodologies
- Be familiar with drug development and medical device development and marketing authorization processes
- Gain knowledge of GCP and of clinical research regulations in Switzerland, Europe and the United States
- Become skilled at developing Case Report Form (CRF)
- Coordinate the development of clinical trial protocols
- Master effective project planning and management
- Know how to manage applications for Ethics Committee (EC) and Regulatory Authority (RA)
- Understand and implement Quality Systems used in Clinical Trials
- Understand the issues related to research subject protection
Programme
9 modules:听
- Principles and Methods of Clinical Research
- Ethical and Legal Aspects
- Non-Clinical Development and Clinical Pharmacology
- Safety Management and Drug Development
- Clinical Trial Planning and Set-Up
- Clinical Trials Conduct and Close-Out
- Audits and Inspections
- Chemistry, Manufacturing and Controls (optional)
- Clinical Development of anti-cancer and anti-infective vaccines (optional)
- Medical Devices
Dissertation
Students may choose between:
- An internship/work placement in a pharmaceutical company, a Clinical Research Organisation (CRO) or a Clinical Trial Unit in a AV短视频 Hospital (320 hours: two months full-time work or its equivalent on a part-time basis) followed by a report. It is the student's responsibility to find a work placement/internship. The DAS office regularly publishes vacancies, but students may find an offer elsewhere.
- The development of a Clinical Trial protocol or a literature review and dissertation.
Director(s)
Prof. Youssef DAALI听and Prof.听Fran莽ois CURTIN,听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)
Date(s)
22 September 2025
23 September 2025
24 September 2025
Fee
1800 CHF
Speakers
Dr Cyril Jaksic, Mr Antoine Poncet, Dr Ma毛l Barthoulot
Description
- Development of research questions and choice of endpoints
- Study designs
- Statistical methods used in clinical research
- Principles of Randomized Controlled Trials (RCT)
- Critical review of publications
- Development of study protocols
- Choice of endpoints
- Sample size calculation
- Interim analysis planning
Date(s)
13 October 2025
14 October 2025
15 October 2025
Fee
1800 CHF
Speakers
Prof Samia Hurst, Dr Emilie Alirol, Dr Brigitte Happ
Description
- Fundamentals of clinical research ethics
- Informed consent process
- Purpose and function of research Ethics Committees (EC)
- Assessing risks and benefits to research participants
- Regulatory requirements听 of trials investigating drugs, medical devices, and in vitro diagnostics
- Good clinical practices
- Clinical trials authorizations
- Ethical issues in biobanks
Registration for this module only here >> M3 individual registration link <<
Date(s)
3 November 2025
Fee
1000 CHF
Speakers
Dr Val茅rie Nicolas, Dr Catherine Deloche, Dr Marie-Paule Simonin, Dr Anne Vaslin-Chessex
Description
- Pharmacodynamics
- Pharmacokinetics
- Toxicology
- Drug metabolism
- Investigational Medicinal Product Dossier (IMPD) and Investigator Brochure (IB)
Date(s)
24 November 2025
25 November 2025
Fee
1400 CHF
Speakers
Prof Fran莽ois Curtin, Dr Fabiana Tirone
Description
- Risk management and safety monitoring during product development
- Safety assessment, documentation and reporting during clinical trials
- Pre-and post-marketing pharmacovigilance
- Role of Data and Safety Monitoring Boards (DSMB)
Date(s)
19 January 2026
20 January 2026
21 January 2026
Fee
1800 CHF
Speakers
Dr Shelly Bustion, Dr Sandrine Charvat
Description
- Essentials of Clinical Trial Management
- Budget development and resource planning
- Investigator sites selection
- Role of CROs and external providers
- Clinical trial documents
- Submission to Ethics Committee (EC) and Regulatory Authorities (RA)
- Logistics planning: Investigational Products and other Clinical Trial supplies
Registration for this module only here >> M7 individual registration link <<
Date(s)
9 February 2026
10 February 2026
11 February 2026
Fee
1800 CHF
Speakers
Dr C茅cile Nicolas-Denizou, Dr Niloufar Marsousi
Description
- Essentials of clinical trial monitoring
- Recruitment and retention of study subjects
- Data collection and data management
- Management of investigational product
- Documents and record
- Risk management
- Root-cause analysis
- Trial close out activities
- Study report
Registration for this module only here >> M8 individual registration link <<
Date(s)
9 March 2026
10 March 2026
11 March 2026
Fee
1800 CHF
Speakers
Dr Isabelle Mercier, Dr Isabelle Semac
Description
- Quality management systems
- Audit
- Purpose and conduct of regulatory inspections
- Site preparation to inspections
Registration for this module only here >> M12 individual registration link <<
Planning
Dates to be confirmed
Date(s)
12 March 2026
Fee
1000 CHF
Speakers
Dr Lucie Bouchoud, Prof Farshid Sadeghipour, Dr Laurent Carrez
Description
- Explanation of the GMP (good manufacturing practice)
- Quality Assurance of the drug
- Qualification and Validation (premice, equipment)
- Raw material for drug manufacturing
- What can be manufactured by a hospital pharmacy for clinical trials?
Planning
Dates to be confirmed
Date(s)
12 March 2026
Fee
1000 CHF
Speakers
Dr Val茅rie Dutoit-Vallotton, Prof Carole Bourquin
Description
- Preclinical vaccine development and prerequisites for clinical trials
- Vaccine-relevant immunology: pathways to immunogenicity against infectious antigens and neoplastic cells
- Good Manufacturing Practice (GMP) in vaccine production
- Quality Assurance in vaccine production and testing
- Phases of clinical testing of anti-infective and anti-cancer vaccines
听
Planning
Dates to be confirmed
Date(s)
11 May 2026
12 May 2026
Fee
1400 CHF
Speakers
Dr Mariagrazia Di Marco, Me Gabriel Avigdor
Description
- Overview of Medical devices (MD) development
- EU regulations (MDR, IVDR)
- Qualification and classification of MDs
- Clinical investigation and clinical trial application to authorities
- Market access strategy
- Materiovigilance
- Conformity assessment and CE marking
- Digital health and medical software
- Combination products
Registration for this module only, click here >> M11 individual registration link <<
Planning
Dates to be confirmed
Assessment
Online exams. Each module is assessed a few weeks after the end of the module.
End of DAS dissertation:
For this students may choose between:
> A vocational training/internship (320 hours) in a pharmaceutical company, a Clinical Research Organisation (CRO) or a Clinical Trial Unit in a AV短视频 Hospital followed by a report.
> The development of a Clinical Trial protocol or a literature review and dissertation.
End of DAS dissertation:
For this students may choose between:
> A vocational training/internship (320 hours) in a pharmaceutical company, a Clinical Research Organisation (CRO) or a Clinical Trial Unit in a AV短视频 Hospital followed by a report.
> The development of a Clinical Trial protocol or a literature review and dissertation.
Pedagogical method
Lectures, interactive seminars, workshops, vocational training. Teaching is in English.
Diploma awarded
Participants who successfully complete the programme will be awarded the Diploma of Advanced Studies (DAS) in Management of Clinical Trials 鈥� Good Clinical Practice Implementation and Quality Processes / Dipl么me de formation continue (DAS) en Gestion des essais cliniques 鈥� Mise en application des bonnes pratiques cliniques et processus qualit茅 delivered by the AV短视频.
Good Clinical Practice implementation and quality processes provide a theoretical and practical understanding of how these principles are shaping each step of a Clinical Trial, including study design, trial management, and conduct.
Admission criteria
- Title of physician
- Or Master鈥檚 or Bachelor鈥檚 degree in Life Science or title deemed equivalent
- Or bachelor鈥檚 degree from a Swiss AV短视频 of Applied Sciences plus a minimum of 1 year professional experience in the field of the DAS
- Good level of English (B2-C1)
The candidates who follow the programme during their working time must provide written authorization from their employer.
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听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, Associate Professor, 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
- Curriculum Vitae
- Copies of relevant university degrees
- Covering letter
- Two reference letters
- Written authorisation from their employer, if applicable
Cancellation Policy
Any withdrawal before the start of the programme will incur an administration fee of CHF 500.-. Fees will be payable in full once the course has begun.
Schedule
Monday, Tuesday, Wednesday
Remarks
Candidates are advised that a significant amount of self-study is required to complete the DAS and that they are expected to carry out preparatory work before each module. Students should therefore allow sufficient time for home study in addition to attending lectures.
Examinations will take place at a specific date and time, usually a few days before the start of the next module. Candidates must ensure that they are available for these assessments.
Testimonial Oksana Fiammingo, alumna DAS
Contribution to the SDGs
Related programmes
- MAS - Drug Discovery and Clinical Development (2025)
- Session - Management of Clinical Trials 鈥� Ethical and Legal Aspects (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)