Management of Clinical Trials (2023)

LocationGeneva, Lake Geneva region, Switzerland
CategoryPharmacology
Health
typeDAS

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 )
 

CHF 9’000.- for the Diploma
1-day-module: CHF 1’000.-
2-day-module: CHF 1’400.-
3-day-module: CHF 1’800.-

  • 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

Medical doctors, biologists, pharmacists, veterinarians, nurses, biochemists and other professionals involved, or wishing to gain skills and knowledge, in the field of clinical research.

  • 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

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:

  • 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

Director(s)

Prof. Youssef DAALI and Prof. François CURTIN, Faculty of Science and Faculty of Medicine, University of Geneva

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)

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.

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.

  • 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.

  • 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

  • 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 Angela Huttner , Head of Clinical Investigation Unit (CRC), University Hospitals of Geneva (HUG)
  • Dr Françoise Lascombes , External Consultant
  • Dr Guillaume Perriard , Lead Patient Engagement, Novartis Pharma Switzerland
  • 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

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.

In your contacts, please refer to myScience.ch
and reference edu.myScience.ch/id4592