Medicinal products



Environmental Risk Assessment of Medicinal Products

Learn how to perform an environmental risk assessment (ERA) of drug substances according to the European Medicines Agency (EMA). The ERA must accompany an application for a marketing authorisation for a medicinal product.

You will be introduced to:

  • general principles of the phased assessment methods and the regulation behind
  • PBT (persistent, bioaccumulative, toxic) assessment and how to estimate substance concentrations in the environment
  • data requirements for a Phase 2, Tier A assessment
  • when to perform an extended analysis, i.e. the Tier B assessment
  • principles and examples of studies related to the environmental fate of a substance  and effect studies on aquatic and terrestrial organisms 
  • structure and contents of the expert environmental risk assessment report

Target group
The course is directed at staff in pharmaceutical companies working with regulation or evaluation of human medicinal products on the EU market.

After the course
you will be able to

  • understand the legislative requirements
  • decide when to perform an environmental risk assessment of a drug substance
  • understand the principles in the fate and effects studies
  • know how to design a cost effective test program, and you will have an overview of the steps in the environmental risk assessment and the expert report.

Course leader
Margrethe Winther-Nielsen, PhD Environmental Biotechnology. Comprehensive experience in hazard and risk assessment, GLP studies and quality assurance.

Course structure
The course is a mixture of lectures and hands-on exercises. The training encourages dialogue and interaction among the participants.

Date and venue
The course is held upon request or it can be customised as a company course.

Further information
Vibeke Salmon
Tel.:  4516 9144
ves@dhigroup.com

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Vibeke Salmon

ves@dhigroup.com