FLVKB0381 Clinical Drug Development

To give the students knowledge to preclinical and clinical methods used as basis for registering drugs. Furthermore to provide a description of the main areas, processes and key functions in the pharmaceutical industry that contributes to planning, design and practical conduct of clinical drug development.

Course teaching is based on the assumption that students have knowledge corresponding to the content of the courses Basic Pharmacology, Organ-related Pharmacology, Pharmacotherapy, Toxicology/Occupational Health and Drug Production.

The regulatory guidelines and principles around pre-clinical and clinical research will be reviewed. The core focus areas will be:

• Regulatory requirements for clinical trial protocols in Denmark and abroad.
  • the Danish Medicines Agency
  • the Ethics Committee system and
  • Data Protection Agency
• Principles for the development of pre-clinical documentation, including
  • discovery
  • preclinical safety pharmacology and
  • toxicology.
• Clinical drug development, including
  • Clinical Research Methodology – the randomised clinical study design
  • Clinical Trials
    • Human Pharmacology
    • Therapeutic Exploratory
    • Therapeutic Confirmatory
    • Therapeutic Use
    • Health Economy/Outcomes Studies
  • Good Clinical Practice
  • The pharmaceutical industry’s involvement in the development of clinical development plans and protocols
  • the Conduct and Monitoring of Clinical Trials
  • Clinical Supply Chain Activities, incl. Study Drug Management
  • Safety Surveillance and Pharmacovigilance
  • Clinical Research from the Investigator Perspective
  • Data Management
  • Medical Writing and Study Publications
  • Medical Devices
  • Quality Assurance
  • Audits and Inspections
• Project report, in which the students during the last weeks of the course will develop of clinical trial protocol based on a medical case.

At the end of the course, students are expected to be able to:

• Describe the regulatory requirements for pre-clinical and clinical trials used to register drugs.
• Describe the clinical development process of a drug in the pharmaceutical industry
• Describe the main principles of Good Clinical Practice, including roles/responsibilities of sponsors, monitors and investigators.
• Describe the main quality assurance aspects and ethical dimensions of importance in clinical drug development.
• Develop clinical trial protocols for studies in healthy volunteers and patients

Lona Christrup, Institut for Farmakologi og Farmakoterapi