2 October 2023

Clinical Pharmacology and Biostatistics

Understand the clinical pharmacological considerations during drug development and take active part in the planning, organization and execution of clinical trials.

Course: Clinical Pharmacology and Biostatistics

The course covers the transition process of drug candidates from the preclinical stage to clinical evaluation comprising selection of special patient populations, PK/PD methodology, clinical trial designs, and regulatory aspects. Special emphasis will be put on biostatistics including theory, considerations and hands-on calculations for practical use. Further an introduction will be given to in silico trial simulation.

The course is suitable for employers of the pharmaceutical industry who work with translational aspects of drug development: from non-clinical to clinical development. It is for those who want to get improved competences for writing a clinical protocol and monitor a clinical trial.












The course prepares you to be an active participant when a clinical protocol has to be planned, written and executed.

Thus on top of the necessary basic knowledge on biostatistics, pharmacometrics  and clinical pharmacology considerations it enables you to become an active  partner in the planning and execution of a clinical trial.

You will learn to:

  • write a protocol on a clinical trial to be valid for the clinic
  • calculate statistics and the power of a clinical study
  • plan and critically evaluate a clinical trial
  • handle translational information from the preclinical to the clinical setting
  • identify a special patient population for the trial
  • liaise and communicate professionally using clinical pharmacology and clinical trial terminology.








































Course details

Duration: 10 days on campus
Dates: 2-6 + 23-27 October 2023
Frequency: Only available every second year
Place: University of Copenhagen, Copenhagen, Denmark
Course fee: EU/EEA citizens: 21,500 DKK
Non-EU/EEA citizens: 24,975 DKK

The fee includes lunch/coffee.

Payment conditions

Level and credit: Master course; 5 ECTS
Examination date: Announced in the winter 2023/2024 exam plan
Application deadline: 8 weeks prior to course start
Admission: To be admitted, you must meet the admission criteria for Master of Industrial Drug Development

Course dates and application deadlines are announced via the  programme newsletter.
Download course curriculum