Health

DAS Management of Clinical Trials 2024

Announcement: Registrations for DAS Management of Clinical Trials 2024-2025 are open!

• Next information session - May 27, 2024 from 10 AM to 11 AM >> Zoom link
   
• Registration for individual modules is possible througout the year, up to 4 weeks before the module starts (by email: das-mas-clinical(at)unige.ch)
   
• Stay updated on upcoming courses - follow us on >> Linkedin!

Information

Period

Language

Format

Contact

Location

Registration

Registration deadline

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

• Home
• Detailed programme
• Additional information
• Testimonials

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: 

• 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)

Accreditation

Module 2 | Principles and Methods of Clinical Research

Date(s)

Fee

Speakers

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

Module 3 | Ethical and Legal Aspects

Date(s)

Fee

Speakers

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

Module 4A | Preclinical Pharmacology, Toxicology and Clinical Pharmacology

Date(s)

Fee

Speakers

Description

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

Module 5 | Safety Management and Drug Development

Date(s)

Fee

Speakers

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)

Module 7 | Clinical Trials Set-up and Conduct

Date(s)

Fee

Speakers

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

Module 8 | Clinical Trials Conduct and Close out

Date(s)

Fee

Speakers

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

Module 10A | Chemistry, Manufacturing and Controls

Date(s)

Fee

Speakers

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?

Module 10B | Clinical Development of anti-cancer and anti-infective vaccines

Date(s)

Fee

Speakers

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
   

Module 11 | Medical Devices

Date(s)

Fee

Speakers

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

Module 12 | Audits and Inspections

Date(s)

Fee

Speakers

Description

• Quality management systems
• Audit
• Purpose and conduct of regulatory inspections
• Site preparation to inspections

Assessment

Pedagogical method

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

Diploma awarded

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, 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.

Contribution to the SDGs

Related programmes

• MAS - Drug Discovery and Clinical Development (2025)