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.
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.
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.
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.
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 about the formal requirements in the admission criteria.
Course responsible
Professor Morten Andersen, University of Copenhagen
Visiting experts from the pharmaceutical industry
Alejandra Mørk, Klifo
Christian Gluud, CTU, Rigshospitalet – Copenhagen University Hospital
Connie Brendstrup, Roche
Ewa Lindenstrøm, EL Medical Consulting
Frank Larsen, Lundbeck
Helle Northeved, Lundbeck
Jane Arce, Nordic Trial Operations
Jens Peter Balling, Lundbeck
Judith Jacobsen, Statcon ApS, Biostatistic Department, University of Copenhagen
Mette Damholt, Rigshospitalet - Copenhagen University Hospital
Morten Mau-Sørensen, Finsen Institute
Ove Andersen, Hvidovre Hospital
Henrik Enghusen Poulsen, SUND
Trine Meldgaard Lund, SUND
Birgitte Søgaard, Lundbeck
Camilla Buoen, NovoNordisk
Mette Due Theilade, DMA
Steffen Thirstrup,NDA Group
Rune Vig Overgaard, NovoNordisk
Andrew Hooker, Uppsala University
Karin Friis Back
List of lecturers may be subject to change.
This course is offered as an compulsory course in the Master of Industrial Drug Development programme.
Priority is given to students enrolled on Master of Industrial Drug Development. Once the enrolled students have been admitted to the course, the remaining seats are distributed on a first-come, first-served basis.
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. |
| 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