Reality-based ERAs
​Risk identification
During this initial stage, potential environmental hazards or threats are recognized and catalogued. This involves understanding and listing out various environmental stressors that may cause harm to the environment or human health.
Risk analysis
This stage delves deeper into understanding the nature and severity of the identified risks, often by quantifying the likelihood and magnitude of the potential impacts. Various methodologies determine exposure levels and consequences.
Risk assessment
In this concluding phase, the information from the risk analysis is utilized to make determinations about the overall risk posed by the identified hazards, weighing their significance and determining the need for mitigation measures.
Directive 2001/83/EC
Directive 2001/83/EC states that ERAs are necessary for new marketing authorization applications (MAA) of medicinal products or variations thereof. The main objective of ERAs is to systematically investigate chemicals applied within drugs and medicinal use, and chemicals which are intended for respective applications. In this context, the focus of ERAs lies on the analysis of applied chemicals and chemicals intended for use and whether they can be processed as intended without causing adverse effects to human health or the environment.
Your benefits
The process of preparing ERAs requires interdisciplinary collaboration, rigorous data analysis, and adherence to established guidelines and regulations. It aims to provide scientifically sound and reliable information to guide informed decision-making and minimize potential ecological risks.
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At IASON consulting we provide:
Interdisciplinary in-house capabilities
Unbiased opinion
Familiarity with latest regulatory requirements
Frequently asked questions
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