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Lieky – hodnotenie environmentálneho rizika (ERA) – *Webinár*
Medicines - Environmental Risk Assessment (ERA) - *Webinar*
Event by: Karta bezpečnostných údajov
Online event
Talks & discussions
About event
The webinar provides an overview of the status and processes of Environmental Risk Assessment (ERA) for human medicinal products.
Documentation for marketing authorization for human medicinal products includes Environmental Risk Assessment (ERA).
Compliant with Article 8 para. 3 letters c) and g) of Directive 2001/83/EC, as amended, an assessment of the potential environmental risks posed by medicinal products in terms of their impact on the environment should be submitted.
Environmental Risk Assessment (ERA) is concerns the risks to the environment resulting from the use, storage and disposal of the drug.
ERA represents a gradual, two-phase procedure. The first phase (Phase I) estimates environmental exposure to the medicinal substance by calculating the predicted environmental concentration (PEC). The PEC calculation applies to the aquatic environment.
ERA is based on the evaluation of the product in terms of physico-chemical properties, ecotoxicological and behavioral properties of its active substance. The assessment of potential risks for the environment resulting from the use of the drug is carried out in order to protect aquatic and terrestrial ecosystems, including surface water, groundwater, soil and secondary poisoning.
Who is the webinar intended for
employees responsible for the marketing of human medicinal products...
Documentation for marketing authorization for human medicinal products includes Environmental Risk Assessment (ERA).
Compliant with Article 8 para. 3 letters c) and g) of Directive 2001/83/EC, as amended, an assessment of the potential environmental risks posed by medicinal products in terms of their impact on the environment should be submitted.
Environmental Risk Assessment (ERA) is concerns the risks to the environment resulting from the use, storage and disposal of the drug.
ERA represents a gradual, two-phase procedure. The first phase (Phase I) estimates environmental exposure to the medicinal substance by calculating the predicted environmental concentration (PEC). The PEC calculation applies to the aquatic environment.
ERA is based on the evaluation of the product in terms of physico-chemical properties, ecotoxicological and behavioral properties of its active substance. The assessment of potential risks for the environment resulting from the use of the drug is carried out in order to protect aquatic and terrestrial ecosystems, including surface water, groundwater, soil and secondary poisoning.
Who is the webinar intended for
employees responsible for the marketing of human medicinal products...