DAS Management of Clinical Trials 2024
Announcement: Registrations for individual modules possible up to 4 weeks before the start of the module!
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Information
Period
September 2024 - May 202533 ECTS credits
169 Teaching hours
276 hours of personal work; 540 hours of personal work for the DAS Thesis.
Language
EnglishFormat
On-site – switch over to online-learning if requiredRegistration
Registration deadline
10 July 2024Modules can be followed individually
Registration for individual modules up to 4 weeks before the start of each module
Fees:
CHF 9’000.- 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:
- Principles and Methods in Clinical Research
- Ethical and Legal Aspects
- Preclinical Pharmacology, Toxicology and Clinical Pharmacology
- Safety Management in Drug Development
- Clinical Trials Set-up and Conduct
- Clinical Trials Conduct and Close out
- Chemistry, Manufacturing and Controls (optional)
- Clinical Development of anti-cancer and anti infective vaccines (optional)
- Medical Devices
- Audits and Inspections
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 University 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 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)
Date(s)
23 September 2024
24 September 2024
25 September 2024
Fee
1800 CHF
Speakers
Prof Angèle Gayet-Ageron, Dr Cyril Jaksic, Mr Antoine Poncet, Dr Maël 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)
14 October 2024
15 October 2024
16 October 2024
Fee
1800 CHF
Speakers
Prof Samia Hurst, Dr Emilie Alirol, Dr Brigitte Happ
Description
- Clinical research ethics
- Informed consent process
- Data protection and confidentiality
- Purpose and function of research Ethics Committees (EC)
- Assessing risks and benefits to research participants
- Vulnerable populations
- Good clinical practices
- Legal framework applicable in Switzerland, Europe and the United States for drugs, medical device and non-interventional trials
- Clinical Trial Agreements (CTA) and authorship issues
- Ethical issues in biobanks
Registration for this module only here >> M3 individual registration link <<
Date(s)
11 November 2024
Fee
1000 CHF
Speakers
Dr Valérie 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)
9 December 2024
10 December 2024
Fee
1400 CHF
Speakers
Prof François Curtin, Dr Fabiana Tirone
Description
- Risk management and safety monitoring during drug development
- Safety assessment, documentation and reporting during clinical trials
- Pre-and post-marketing pharmacovigilance
- Role of Data and Safety Monitoring Boards (DSMB)
Date(s)
20 January 2025
21 January 2025
22 January 2025
Fee
1800 CHF
Speakers
Dr Shelly Bustion, Dr Sandrine Charvat
Description
- Scientific, strategic and safety considerations in clinical trial design
- Budget development and resource planning
- Investigator sites selection
- Role of CROs and external providers
- Clinical trial documents
- Submission to Swiss Ethics Committee (EC) and Swiss Regulatory Authorities (RA)
- Risk Management
Registration for this module only here >> M7 individual registration link <<
Date(s)
17 February 2025
18 February 2025
19 February 2025
Fee
1800 CHF
Speakers
Dr Cécile Nicolas-Denizou, Dr Niloufar Marsousi
Description
- Project management applied to clinical trials
- Recruitment and retention of study subjects
- Management of randomization and blinding systems
- Data collection and data management
- Management of investigational medicinal product
- Monitoring of clinical studies
- Clinical trial close out activities
- Statistical analysis plan
- Data cleaning and data base lock
- Clinical study report
- Safety reconcilation
Registration for this module only here >> M8 individual registration link <<
Date(s)
17 March 2025
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?
Date(s)
17 March 2025
Fee
1000 CHF
Speakers
Prof Carole Bourquin, Dr Valérie Dutoit-Vallotton
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
Date(s)
18 March 2025
19 March 2025
Fee
1400 CHF
Speakers
Dr Mariagrazia Di Marco, Me Gabriel Avigdor
Description
- Medical devices (MD) and new EU regulations (MDR, IVDR)
- Qualification and classification
- Clinical investigation and clinical trial application to authorities
- Market access strategy
- Conformity assessment and CE marking
- Materiovigilance
- Digital health and medical software
- Combination products
Registration for this module only here >> M11 individual registration link <<
Date(s)
12 May 2025
13 May 2025
14 May 2025
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 <<
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 University 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 University 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 – 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 University of Geneva.
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’s or Bachelor’s degree in Life Science or title deemed equivalent
- Or bachelor’s degree from a Swiss University 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, 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, Associate Professor, 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
- 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 – 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)