Formation continue

Drug Discovery and Clinical Development

Objectives

  • Provide essential business knowledge of drug and medical devices in clinical research and development
  • Give health professionals the tools to comply with the highest scientific and ethical standards in clinical research
  • Empower physicians and health scientists to lead clinical trials within hospitals, pharmaceutical and biotechnology companies
  • Enable health professionals to gain a strategic vision of clinical development and navigate the complexities of bringing new medicinal products to the global market

Audience

Medical doctor, biologist, pharmacist, nurse, biochemist and other professional involved, or wishing to gain skills and knowledge, in the field of drug discovery and development

Learning outcomes

  • Understand the stakes, challenges and opportunities of drug discovery and development
  • Master the fundamental scientific and ethical principles of drug discovery and development
  • Gain knowledge of Good Clinical Practices (GCP) and of clinical research regulations in Switzerland, Europe and the United States
  • Learn how to navigate clinical trial authorization and marketing authorization processes
  • Master effective planning and management for clinical trials
  • Successfully manage partnerships with pharmaceutical and biotechnology partners
  • Understand the issues related to research subject protection
  • Understand and take up the challenges of new technologies and personalized medicine

Programme

12 modules:

  • Introduction to Clinical Development: Challenges and Prospects
  • Principles and Methods of Clinical Research • Ethical and Legal Aspects
  • Preclinical Pharmacology, Toxicology and Clinical Pharmacology
  • Safety Management and Drug Development • Medical Statistics and Trial Methodologies
  • Clinical Trials Set-up and Conduct part 1
  • Clinical Trials Set-up and Conduct part 2
  • Regulatory Considerations in Drug Development
  • Clinical Trials Close-out and Reporting
  • Audits and Inspections
  • New Perspectives, Personalized Medicine and New Therapeutics

Thesis

Director(s)

Prof. Jules DESMEULES, Faculty of Medicine, University of Geneva and Dr. François CURTIN, GeNeuro

Coordinator(s)

Dr. Victoria ROLLASON, University of Geneva

Accreditation

This programme is accredited by Swissethics, Swiss Association of Pharmaceutical Professionals, Swiss Society of Clinical Pharmacology and Toxicology, Swiss Institute for postgraduate and continuous medical education
 
12 février 2019
  MAS