Clinical Pharmacology and Biostatistics – University of Copenhagen

Master of Industrial Drug Development > Courses > Clinical Pharmacology ...

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.

What do you gain?

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.

Thus you 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

We have assembled a unique team of both industrial and academic speakers. The mixture between academia and industry speakers gives you a well-rounded perspective on biostatistics, pharmacometrics and clinical pharmacology. The course gives you the possibility to write a complete clinical protocol on your own and defend your choices taken regarding effect parameters, safety  and statistics.

Course dates

  • Expected to be offered in autumn 2019. Not scheduled yet.

Course fee

  • DKK 21,500 for EU/EEA citizens
  • DKK 24,975 for non-EU/EEA citizens