DAS Management of Clinical Trials 2020
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.
Information
Period
September 2020 - May 202133 ECTS credits
160 Teaching hours
Language: bilingual French/English
Language
EnglishFormat
On-siteRegistration
Registration deadline
31 July 2020Modules can be followed individually
Fees:
CHF 7’500.- for the Diploma
CHF 1’500.- for individual modules
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 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 François Curtin, Faculty of Medicine, University of Geneva
Dr Catherine Deloche, Solid Drug Development
Dr Françoise Lascombes, External Consultant
Dr Catherine Deloche, Solid Drug Development
Dr Françoise Lascombes, External Consultant
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)
Candidates who follow the programme during their working time must provide written authorization from their employer.
Schedule
Monday, Tuesday, Wednesday
Contribution to the SDGs