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Course module: BMB508416
BMB508416
Specialisation Programme Pharmacoepidemiology
Course info
Course codeBMB508416
EC13
Course goals
At the end of this course, the student:
  1. has insight in the basic terminology and principles specific for clinical epidemiology;
  2. has insight in the different aspects of clinical epidemiological research (diagnostic / prognostic / therapeutic / etiologic, i.e. causal / descriptive);
  3. is able to determine a clinical research question that includes outcome, determinants and domain;
  4. has knowledge of the different study designs and design aspects used in clinical epidemiology;
  5. is able to design a clinical epidemiological study;
  6. has knowledge of the data-analysis techniques that are used for the different aspects of clinical epidemiological research;
  7. is able to choose and apply the appropriate basic techniques to analyse data of a clinical epidemiological study using the statistical package SPSS;
  8. is able to interpret the results of basic data analyses of a clinical epidemiological study;
  9. understands the concepts of bias, and the statistical issues concerning confounding bias;
  10. is able to read and understand clinical epidemiological scientific papers and recognize, in these papers, which study design and data analysis techniques were used;
  11. has insight in the basic design principles of a randomized controlled trial;
  12. has an overview of specialized design options for a randomized controlled trial;
  13. has insight in the basic principles of data analysis of a randomized controlled trial;
  14. has an overview of more specialized principles of data analysis of a randomized controlled trial;
  15. has insight in the principles of drug risk assessment and how to evaluate potential side effects of medication;
  16. has an overview of current regulatory principles for the conduct of randomized controlled trials;
  17. has an overview of common practical issues in the conduct of a randomized controlled trial and suitable solutions;
  18. is able to design a valid randomized controlled trial for any intervention;
  19. is able to read, understand and appraise epidemiological scientific papers on randomized controlled trials;
  20. has insight in the principles of drug risk assessment and how to evaluate potential side effects of medication;
  21. has an overview of current regulatory principles for the conduct of randomized controlled trials;
  22. has an overview of common practical issues in the conduct of a randomized controlled trial and suitable solutions;
  23. is able to design a valid randomized controlled trial for any intervention;
  24. is able to read, understand and appraise epidemiological scientific papers on randomized controlled trials;
  25. has insight into current developments in pharmaceutical policy making as well to give a better understanding of the methods available for analysing the effects of policy interventions;
  26. knows about the typical problems (e.g. confounding by indication, rare side effects) and approaches to deal with these problems in the practice of Pharmacoepidemiology.
Content
Period (from – till): short courses during whole study year

Contact details: Educational Office Epidemiology
E-mail: msc-epidemiology@umcutrecht.nl

Registration:
https://epidemiology-education.nl/ – learning environment
 
Lecturer(s):
Staf, dept. pharmacoepidemiology & pharmacotherapy, Farmacie, UU
Staf Julius Centrum

Description:
Each student is expected to attend so called ‘specialisations’. Each specialisation consists of obligatory and free to be chosen courses. These lecture days of choice should concise of (advanced) epidemiological or statistical courses. Listed below are the courses per specialisation.
 
Pharmacoepidemiology (PE) – program director Prof O.H. Klungel
6 EC with the following obligatory courses
Clinical Trials and Drug Risk assessment (1.5EC)
Clinical Epidemiology (1.5EC)
Pharmacoepidemiology & Drug Safety (1.5EC)
Pharmaceutical Policy Analysis (1.5EC)

Add other courses to reach the total amount of EC’s for the specialisation programme *

* These other courses do not need to be within the same specialisation, but they do need to:
  • be epidemiological courses and/or statistical courses and/or;
  • be for PhD students with a TSA, part of the obligatory programme specific courses at the PhD program the student is enrolled in.
Literature/study material used
depending on chosen courses

Mandatory for students in own Master’s programme:
N.A.

Optional for students in other GSLS Master’s programme:
No

Prerequisite knowledge:
Introduction to Epidemiology
Introduction to Statistics
Study Design in Etiologic Research
Classical Methods in Data Analysis
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