Risk assessment
Course infoSchedule
Course moduleMED-BMS60
Credits (ECTS)3
CategoryMA (Master)
Language of instructionEnglish
Offered byRadboud University; Faculty of Medical Sciences; Biomedische wetenschappen;
Contactperson for the course
dr. ir. P.T.J. Scheepers
Other course modules lecturer
dr. ir. P.T.J. Scheepers
Other course modules lecturer
Academic year2017
2  (02/10/2017 to 25/08/2018)
Starting block
Course mode
RemarksPeriod 2b, Thursday and Friday
Registration using OSIRISNo
Course open to students from other facultiesYes
Pre-registration openfrom 01/04/2017 up to and including 04/09/2017
Waiting listYes
Placement procedureDone manually by Back Office
ExplanationDone manually by Back Office
The main objectives of this module are:
After completion of the course, students are able to:
  1. The student is able to correctly apply terminology in the risk assessment process.
  2. The student can perform a hazard identification based on declared product information
  3. The student can acquire and select data suited to serve in a specific risk assessment setting
  4. The student can determine adverse health effects and determine a critical effect size
  5. The student can apply dose-response theory to different types of endpoints (threshold/non- threshold)
  6. The  student  can  identify  uncertainties  and  deal  with  them  appropriately  by  use  of assessment factors
  7. The student can perform a complete quantitative human health risk assessment procedure for a single physical determinant and defend it in a scientific meeting with peers.
  8. The student is able to communicate the results of risk assessment to policymakers
The module 

Human health risk assessment (HRA) is generally applied to establish safe levels for all (marketed) products and for all other physical factors encountered in the living and working environment and known or suspected to cause adverse health effects. HRA is also applied to new/emerging risks. This course focuses on the generic method of HRA that is based on a paradigm that was originally established by the National Research Council (NRC, 1983). This approach evolved over the years to a complex procedure that is still being improved.
HRA is primarily applied for the purpose of prevention but can also be used in response to concerns from the public and to incidents and disasters. Recent examples include the health impact of the use of rubber granulate in synthetic turf pitch on soccer fields, of Schiphol airport on inhabitants (noise), of agricultural activities, such as in the Q-fever incident (biological agents), and of working with chromium among former military personnel. In addition, the HRA method can be used to assess the safety (and risks) of certain food products, medication, and consumer products, such as cosmetics.
Most of these determinants contribute to the etiology of multiple types of reversible and irreversible health endpoints including for example respiratory disease, cardiovascular disease, neurologic disease, adverse reproductive outcomes, and different types of cancer. Some environmental factors also interact with genetic traits, whereas others interact with e.g. life style factors or prescribed medication.
Well-known safety standards are established for e.g. noise, industrial chemicals, air quality, medication, and ionizing radiation (radon). In the Netherlands, most risk assessments are performed on a national level (RIVM and Health Council). In Europe, standards are set by EU authorities (EFSA, ECHA, EMA, SCOEL and SCHEER) and by international bodies (WHO). The use of human data is preferred, but such data are often not available and extrapolations from bioassay results need to be applied.

Instructional modes
Working group

Period 2b Thursday and Friday

Course examination
Test weight1
OpportunitiesBlock 2, Block 2