Interested in our MAS or DAS programmes?
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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
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
Registration
Registration deadline
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
Credits
Teaching hours
Schedule
Generally between Monday and Wednesday (approx. 8AM-6PM), depending on the module.
Date(s)
Fee
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
Date(s)
Fee
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
Date(s)
Fee
Description
- Pharmacodynamics
- Pharmacokinetics
- Toxicology
- Drug metabolism
- Investigational Medicinal Product Dossier (IMPD) and Investigator Brochure (IB)
Speakers
Date(s)
Fee
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
Date(s)
Fee
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
Date(s)
Fee
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
Date(s)
Fee
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
Date(s)
Fee
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
Date(s)
Fee
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
Date(s)
Fee
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
Pedagogical method
Lectures, interactive seminars, workshops, vocational training. Teaching is in English.
Assessment
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
Director(s)
Prof. Youssef DAALIÌýand Prof.ÌýFrançois CURTIN,ÌýFaculty of Science and Faculty of Medicine, ÓñÃÀÈË´«Ã½
Coordinator(s)
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.
Related programmes
- MAS - Drug Discovery and Clinical Development (2025)
- Session - Management of Clinical Trials – Ethical and Legal Aspects (2024)
- Session - Management of Clinical Trials – Clinical Trials Set-up and Conduct (2025)
- 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)