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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.
This course is a part of
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.
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.
Course director and lecturers on Clinical Pharmacology and Biostatistics
Course details for Clinical Pharmacology and Biostatistics
Dates and examination
Course dates
To be announced.
The course is available every second year, and will be offered next time in 2025.
Examination
Please find the exam dates in the exam plan.
You can find further information about the course and the exam in the course curriculum.
See an overview of all courses on Master of Industrial Drug Development.
Learning outcomes
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.
Admission criteria
Professionals in need of interdisciplinary overview
The course is for professionals in the pharmaceutical industry who need an interdisciplinary overview of the specific requirements for clinical pharmacology and biostatistics.
Course specific academic qualifications
It is recommendable to have completed the MIND course Pharmacology before taking this course.
General admission criteria:
- Hold a relevant bachelor degree or equivalent
- Have a minimum 2 years of relevant job experience in drug development
- Be proficient in English
Find detailed information in the admission criteria on Master of Industrial Drug Development.
Priority is given to enrolled students
This course is offered as a compulsory course in the Master of Industrial Drug Development programme. Priority is given to students already enrolled. Once the enrolled students have been admitted to the course, the remaining seats are distributed on a first-come, first-served basis.
Place
University of Copenhagen
Department of Pharmacy/
Department of Drug Design and Pharmacology
Universitetsparken 2
2100 Copenhagen
Denmark
Contact
Annette Villumsen
Study Administration Officer
Tel.: +45 35 33 60 66