SLVKB0381U Clinical Drug Development

Volume 2013/2014
Education
MSc in Pharmaceutical Sciences - compulsory, MSc in Medicinal Chemistry - elective, Cand.Scient.Pharm. - elective, Cand.Pharm. - elective
Content
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.
Learning Outcome
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.

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.
Literature
Laws, documents, recommendations, circulars, guidelines and scientific papers.
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.
•Lectures: 40 (50 min.)
•Classroom discussions: 6 (50 min.)
•Case project and report: 70
Compulsory for line 3 of the MSc programme in Pharmaceutical Sciences.
  • Category
  • Hours
  • Lectures
  • 40
  • Preparation
  • 80
  • Preparation
  • 9
  • Project work
  • 70
  • Theory exercises
  • 6
  • Total
  • 205
Credit
7,5 ECTS
Type of assessment
Practical written examination
Course participation
Internal evaluation of project report and satisfactory participation in the course. Attendance: at least 85% of the scheduled
Marking scale
passed/not passed
Censorship form
No external censorship
Criteria for exam assesment
Internal evaluation of project report and satisfactory participation in the course. Attendance: at least 85% of the scheduled