DAS Management of Clinical Trials 2023
This training programme is conducted in English and French. Both languages are required to enrol in the DAS Management of Clinical Trials!
Information
Period
September 2023 - May 202433 ECTS credits
160 Teaching hours
Language
Bilingual (En/Fr)Format
On-site – switch over to online-learning if requiredRegistration
Registration deadline
30 June 2023Modules can be followed individually
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.-
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 – Part 1
- Clinical Trials Set-up and Conduct – Part 2
- Clinical Trials Close-out and Reporting
- Medical Devices
- Audits and Inspections
Thesis
Director(s)
Prof. Youssef DAALI and Prof. François CURTIN, Faculty of Science and Faculty of Medicine, University of Geneva
Coordinator(s)
Dr François CURTIN, Dr Catherine DELOCHE, Dr Françoise LACOMBE, Faculty of Medicine, 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)
18 September 2023
19 September 2023
20 September 2023
Fee
1800 CHF
Speakers
Dr Angèle Gayet-Ageron - Prof François Curtin
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)
16 October 2023
17 October 2023
18 October 2023
Fee
1800 CHF
Speakers
Prof. Samia Hurst - Prof. Philippe Ducor - 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
Date(s)
13 November 2023
Fee
1000 CHF
Speakers
Dr Valérie Nicolas - Prof. Youssef Daali - Dr Catherine Deloche - Dr Marie-Paule Simonin
Description
- Pharmacodynamics
- Pharmacokinetics
- Toxicology
- Drug metabolism
- Investigational Medicinal Product Dossier (IMPD) and Investigator Brochure (IB)
Date(s)
4 December 2023
5 December 2023
Fee
1400 CHF
Speakers
Dr Victoria Rollason - Dr François Curtin - Prof. Jules Desmeules
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)
15 January 2024
16 January 2024
17 January 2024
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
Date(s)
26 February 2024
27 February 2024
28 February 2024
Fee
1800 CHF
Speakers
Ms Jennifer Kealy - Ms Virginie Lemeaux
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
Date(s)
18 March 2024
Fee
1000 CHF
Speakers
Dr Lucie Bouchoud, Dr 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)
18 March 2024
Fee
1000 CHF
Speakers
Dr Angela Huttner, 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
Date(s)
19 March 2024
20 March 2024
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
Date(s)
13 May 2024
14 May 2024
15 May 2024
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
Assessment
Students may choose between:
A vocational training in a pharmaceutical company, a Clinical Research Organization (CRO) or a Clinical Trial Unit in a University Hospital (3-4 months) followed by a report.
The development of a Clinical Trial protocol or a literature review and dissertation.
A vocational training in a pharmaceutical company, a Clinical Research Organization (CRO) or a Clinical Trial Unit in a University Hospital (3-4 months) 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 or in French.
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 understanding of both French (knowledge equivalent to B2 Level) and English (knowledge equivalent to the Cambridge First Certificate)
- 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
- Prof. Cem Gabay, Dean of the Faculty of Medicine, University of Geneva
- Prof. Bernard Hirschel, 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, University Hospitals of Geneva
- Prof. Jérôme Pugin, President of the Clinical Research Center (CRC), University Hospitals of Geneva, Faculty of Medicine, University of Geneva
Scientific committee
- Dr Gabriele Ackermann, Chief Scientific Officer ad interim, Therapeutic Area Head Cardiovascular, Renal & Metabolism Therapeutic Area Head Respiratory, Novartis Pharma Switzerland
- Dr Emilie Alirol, Senior Director Clinical Affairs, FIND
- Dr Enrica Alteri, Pharmaceutical consultant, former Head of Human Medicine R&D Support Division, EMA
- Dr Vanya Beltrami, Vice-President, Head of Manufacturing, Anergis, Lausanne
- Prof. Francois Curtin, Medical Director Personalised Health Programmes, Swiss Federal Institute of Technology in Zürich & Lecturer at Hospitals of Geneva (UNIGE)
- 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. Philippe Ducor, Faculty of Law, University of Geneva
- Prof. Marc Froissart, Medical Director of the Clinical Research Centre (CRC), CHUV-UNIL, Lausanne
- Prof. Angèle Gayet-Ageron, Head of the Methodological Support Unit, Clinical Research Centre (CRC), University Hospitals of Geneva, Faculty of Medecine, University of Geneva
- Dr Françoise Lascombes, External Consultant
- Prof. Hervé Porchet, Pharmaceutical consultant
- Dr Victoria Rollason, Division of Clinical Pharmacology and Toxicology, University Hospitals of Geneva and Faculty of Medicine, University of Geneva
Schedule
Monday, Tuesday, Wednesday
Remarks
Candidates are warned that a significant amount of self-study is required to complete the DAS, and that they are expected to go through preparatory work before each module. Students should thus allow sufficient time to study at home, in addition to attending the classroom lectures.
Contribution to the SDGs