Management of Clinical Trials (2018)

 
University of Geneva

LocationGeneva, Lake Geneva region, Switzerland
typeCourse

  • 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 doctor, biologist, pharmacist, nurse, biochemist and other professional 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 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) n Coordinate the development of clinical trial protocols
  • Master effective project planning and management n Know how to manage applications for Ethics Committee (EC) and Regulatory Authority (RA)
  • Understand and implement Quality Systems used in Clinical Trials n Understand the issues related to research subject protection

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

The course is accredited by Swissethics, the Swiss Association of Pharmaceutical Professionals, the Swiss Society of Clinical Pharmacology and Toxicology and the Swiss Institute for postgraduate and continuous medical education.

  • 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)

Related programmes

  • MAS - Drug Discovery and Clinical Development (2018)

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