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Overview

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:Ìý

  • Principles and Methods of Clinical Research
  • Ethical and Regulatory Aspects
  • Non-Clinical Development and Clinical Pharmacology
  • Safety Management During Drug Development
  • Clinical Trial Planning and Set-up
  • Clinical TrialÌýConduct 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 ÓñÃÀÈË´«Ã½ 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.

Diploma awarded

Participants who successfully complete the programme will be awarded the Diploma of Advanced Studies (DAS) in Management of Clinical Trials – Good Clinical Practice Implementation and Quality Processes / Diplôme de formation continue (DAS) en Gestion des essais cliniques – Mise en application des bonnes pratiques cliniques et processus qualité delivered by the ÓñÃÀÈË´«Ã½.

Registration

Registration deadline

1 September 2025
Modules can be followed individually

Fees:

  • CHF 9’000.- for the DAS (9 modules)
  • 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).

Admission criteria

  • Title of physician
  • Or Master’s or Bachelor’s degree in Life Science or title deemed equivalent
  • Or bachelor’s degree from a Swiss ÓñÃÀÈË´«Ã½ 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.

Application File

  • Copy of identity document
  • Curriculum Vitae
  • Copies of relevant university degrees
  • Covering letter
  • Two reference letters
  • Written authorisation from their employer, if applicable

    Applications must be submitted by 15 June 2025. Admission decisions will be communicated latest in the first week of July.Ìý
    >> Update 24.06.2025: We still have a few spots left and are therefore taking registrations until 30 August 2025.Ìý
    Registration for individual modules: up to 4 weeks before the module starts.

    Starting date of the DAS: 22 Sept 2025 (Module 2)

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.


Curriculum

Period

September 2025 - June 2026

Credits

33 ECTS credits

Teaching hours

168 teaching hours

Schedule

Generally between Monday and Wednesday (approx. 8AM-6PM), depending on the module.

Date(s)

22 September 2025
23 September 2025
24 September 2025

Fee

1800 CHF

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

Speakers

Dr Cyril Jaksic, Mr Antoine Poncet, Dr Maël Barthoulot

Date(s)

13 October 2025
14 October 2025
15 October 2025

Fee

1800 CHF

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 requirementsÌý 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 <<

Speakers

Prof Samia Hurst, Dr Emilie Alirol, Dr Brigitte Happ

Date(s)

3 November 2025

Fee

1000 CHF

Description

  • Pharmacodynamics
  • Pharmacokinetics
  • Toxicology
  • Drug metabolism
  • Investigational Medicinal Product Dossier (IMPD) and Investigator Brochure (IB)

Speakers

Dr Valérie Nicolas, Dr Catherine Deloche, Dr Marie-Paule Simonin, Dr Anne Vaslin-Chessex

Date(s)

24 November 2025
25 November 2025

Fee

1400 CHF

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)

Speakers

Prof François Curtin, Dr Fabiana Tirone

Date(s)

19 January 2026
20 January 2026
21 January 2026

Fee

1800 CHF

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 <<

Speakers

Dr Shelly Bustion, Dr Sandrine Charvat

Date(s)

9 February 2026
10 February 2026
11 February 2026

Fee

1800 CHF

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 <<

Speakers

Dr Cécile Nicolas-Denizou, Dr Niloufar Marsousi

Date(s)

9 March 2026
10 March 2026
11 March 2026

Fee

1800 CHF

Planning

Dates to be confirmed

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 <<

Speakers

Dr Isabelle Mercier, Dr Isabelle Semac

Date(s)

24 March 2026

Fee

1000 CHF

Planning

Dates to be confirmed

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?

Speakers

Dr Lucie Bouchoud, Prof Farshid Sadeghipour, Dr Laurent Carrez

Date(s)

24 March 2026

Fee

1000 CHF

Planning

Dates to be confirmed

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
    Ìý

Speakers

Dr Valérie Dutoit-Vallotton, Prof Carole Bourquin

Date(s)

11 May 2026
12 May 2026

Fee

1400 CHF

Planning

Dates to be confirmed

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 <<

Speakers

Dr Mariagrazia Di Marco, Me Gabriel Avigdor

Pedagogical method

Lectures, interactive seminars, workshops, vocational training. Teaching is in English.

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 ÓñÃÀÈË´«Ã½ Hospital followed by a report.
> The development of a Clinical Trial protocol or a literature review and dissertation.

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)
Testimonial Oksana Fiammingo, alumna DAS

Director(s)

Prof. Youssef DAALIÌýand Prof.ÌýFrançois CURTIN,ÌýFaculty of Science and Faculty of Medicine, ÓñÃÀÈË´«Ã½

Coordinator(s)

Prof. François CURTIN, Dr Catherine SUAREZ and Ms Camille Arni, ÓñÃÀÈË´«Ã½

Steering committee

  • Prof. , President of the Section of Pharmaceutical Sciences (ISPOS), Faculty of Science, ÓñÃÀÈË´«Ã½
  • 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 ÓñÃÀÈË´«Ã½ Hospitals
  • Prof Youssef DAALI, Head of the Pharmacological Investigation Unit, Geneva ÓñÃÀÈË´«Ã½ Hospitals, Faculty of Medicine, ÓñÃÀÈË´«Ã½
  • Prof , Director, Institute of Ethics, History and Humanities (iEH2), Faculty of Medicine, ÓñÃÀÈË´«Ã½
  • Dr , President, Catonal Commission on Human Research Ethics, Canton of Geneva
  • Prof Klara POSFAY BARBE, Medical Director, Geneva ÓñÃÀÈË´«Ã½ Hospitals

Scientific committee

  • DrÌý, Senior Director Clinical Affairs, FIND
  • Dr , Pharmaceutical consultant, former Head of Human Medicine R&D Support Division EMA
  • Prof.Ìý,ÌýHead of the Centre for Clinical Research, Lucerne Cantonal Hospital (LUKS), Lecturer at Geneva ÓñÃÀÈË´«Ã½ Hospitals, ÓñÃÀÈË´«Ã½
  • Prof Youssef DAALI, Head of the Pharmacological Investigation Unit. Geneva ÓñÃÀÈË´«Ã½ Hospitals, Faculty of Medicine, ÓñÃÀÈË´«Ã½
  • DrÌý, Chief Operating Officer, Solid Drug Development,Geneva
  • Prof Jules DESMEULES, Faculty of Medicine, ÓñÃÀÈË´«Ã½
  • 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 ÓñÃÀÈË´«Ã½ of Bern
  • Dr , External Consultant
  • Dr , Statistician, Methodological Support unit, Clinical Research Centre (CRC),ÌýGeneva ÓñÃÀÈË´«Ã½ Hospitals
  • Dr , External Consultant
  • Dr , PhD, Lead Patient Engagement, Novartis, Basel
  • DrÌý, PharmD, Division of Clinical Pharmacology and Toxicology, ÓñÃÀÈË´«Ã½ Hospitals of Geneva and Faculty of Medicine, ÓñÃÀÈË´«Ã½

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.

Contribution to the Sustainable Development Goals