Clinical Drug Development

Course 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.
Education

MSc in Pharmaceutical Sciences - compulsory for line 3 

MSc in Medicinal Chemistry - elective

Cand.Scient.Pharm. - elective

Cand.Pharm. - elective

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.

After completing the course the student is expected to be able to:


Knowledge

  • explain preclinical and clinical research methods used as basis for registering drugs. 
  • define, summarize and identify the main areas, processes and key functions in the pharmaceutical industry that contributes to planning, design and practical conduct of clinical drug development.

 

Skills

  • Describe and analyze the regulatory requirements for pre-clinical and clinical trials used to register drugs.
  • Evaluate and put structure to the clinical development process of a drug in the pharmaceutical industry
  • Describe and master the main principles of Good Clinical Practice, including roles/responsibilities of sponsors, monitors and investigators.
  • Assess and discuss the main quality assurance aspects and ethical dimensions of importance in clinical drug development.


Competences

  • independently develop, plan, coordinate and implement clinical trial protocols for studies in healthy volunteers and patients across all 4 phases of Drug Development.

•Lectures: 40 (50 min.)
•Classroom discussions: 6 (50 min.)
•Case project and report: 70

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.

The course can not be attended by students, who also attend the elective course "Kliniske lægemiddelforsøg og GCP" due to partly overlap in the subjects covered.

ECTS
7,5 ECTS
Type of assessment
Practical written examination
Course participation
During the last weeks of the course the students will develop a project report of clinical trial protocol based on a medical case. The assessment will be based on the internal evaluation of project report and satisfactory participation in the course.
Marking scale
passed/not passed
Censorship form
No external censorship
Criteria for exam assessment

To pass the course the student must be able to:

Knowledge

  • explain preclinical and clinical research methods used as basis for registering drugs. 
  • define, summarize and identify the main areas, processes and key functions in the pharmaceutical industry that contributes to planning, design and practical conduct of clinical drug development.

 

Skills

  • Describe and analyze the regulatory requirements for pre-clinical and clinical trials used to register drugs.
  • Evaluate and put structure to the clinical development process of a drug in the pharmaceutical industry
  • Describe and master the main principles of Good Clinical Practice, including roles/responsibilities of sponsors, monitors and investigators.
  • Assess and discuss the main quality assurance aspects and ethical dimensions of importance in clinical drug development.


Competences

  • independently develop, plan, coordinate and implement clinical trial protocols for studies in healthy volunteers and patients across all 4 phases of Drug Development.
  • Category
  • Hours
  • Lectures
  • 40
  • Preparation
  • 80
  • Theory exercises
  • 6
  • Preparation
  • 9
  • Project work
  • 70
  • English
  • 205