DAS Management of Clinical Trials 2019

The DAS in Management of Clinical Trials - Good Clinical Practice Implementation and Quality Processes provides a theoretical and practical understanding of how Good Clinical Practice principles are shaping each step of a Clinical Trial, including study design, trial management and conduct.

Information

Period

September 2019 - May 2020
33 ECTS credits
160 Teaching hours
Language: bilingual French/English

Language

English

Format

On-site

Contact

Location

Geneva

Registration

Registration deadline

31 July 2019
Modules can be followed individually

Fees:

CHF 7’500.- for the diploma
CHF 1’500.- for individual modules

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 doctor, biologist, pharmacist, nurse, biochemist and other professional 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 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

8 modules: 

  • Principles and Methods in Clinical Research
  • Ethical and Legal Aspects
  • Preclinical Pharmacology, Toxicology and Clinical Pharmacology
  • Safety Management and Drug Development
  • Clinical Trials Set-up and Conduct – Part 1
  • Clinical Trials Set-up and Conduct – Part 2
  • Clinical Trials Close-out and Reporting
  • Audits and Inspections

Thesis

Director(s)

Prof. Jules DESMEULES, Faculty of Science and Faculty of Medicine, University of Geneva

Coordinator(s)

Dr Mariagrazia Di MARCO, 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)

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)

Schedule

Monday, Tuesday, Wednesday

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