DAS Management of Clinical Trials 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 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 Duration – Part 2 • Clinical Trials Close-out and Reporting • Audits and Inspections • Thesis September 2018-May 2019 Director 33 ECTS credits Prof. Jules DESMEULES, Faculty of Science and Faculty of Medicine, University of Geneva Registration Deadline Co-ordinator 15 June 2018 Dr. Victoria ROLLASON, University of Geneva Modules can be followed individually Accreditation/Recognition/Certification Information The course is accredited by Swissethics, the Swiss Association of Pharmaceutical Professionals, DAS.Clinicaltrials@hcuge.ch the Swiss Society of ClinicalPharmacology and Toxicology and the Swiss Institute for +41 (0)22 372 9934 postgraduate and continuous medical education unige.ch/formcont/clinicaltrial Université de Genève santé 213