Risk Assessment

An ERA is required for all new marketing authorisation applications for a medicinal product through a centralised, mutual recognition, decentralised or national procedure. For type II variations, the ERA dossier should be updated if there is an anticipated increase in the environmental exposure, e.g. a new indication which results in an increase in the extent of the use.

The risk assessment process, in relation to human health is an essential part of the EU legislation. Spefic requirements and tools are used for the consumers risks assessment and health protection.

The risk assessment process in a worplace, in relation to human health is an essential part of the REACH and occupational protection legal environmant in the European Union.

Environmental risk assessment (ERA) of chemicals is supporting decision making tool in the regulatory context. The webinar is providing the basic frame of the topic.

Exposure scenarios cover the entire life cycle of the substance, including formulation, industrial and professional end-use, consumer use and use in articles. Webinar will provide basic information concerning the ES application under EU legislatory framework.

Chemicals risk assessment under the EU chemicals legislation REACH consists of three components: hazard identification and characterisation, exposure assessment, followed by the risk assessment (characterisation). Webinar is providing explanation on the RA frame, guidelines and applications.