DAS Management of Clinical Trials 2018
• 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
- 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
Registration deadline15 June 2018
CHF 7’500.- for the diploma
CHF 1’500.- for individual modules
- 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).