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.

WHAT YOU WILL LEARN

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 CONTENT

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.

PARTICIPANTS

Participants must meet the following criteria: 
• A relevant bachelor degree or equivalent 
• A minimum of 2 years of relevant job experience 
• Be proficient in English.

COURSE DETAILS

Course dates

10 days, 21-25 October + 4-8 November 2019

Course fee

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

Application deadline

26 August 2019

EXAMINATION

During the course the students work on a trial protocol. The protocol is handed in to the course responsible so early that it can be assessed before the oral examination on the last day. The trial protocol can be written in groups (2-4 persons). 

Each student presents part of the protocol in plenum to be defended for cross examination by the fellow peers, the examinator and the censor. The assessment of the protocol comprises the mode of handling of the posed problem, its solution and the demonstrated level of critical understanding of clinical pharmacology in drug development and the individual oral presentation.

Credit

5 ECTS

Examination date

Oral exam on 8 November 2019