ERA according to revised EMA guideline (EMEA/CHMP/SWP/4447/00 Rev. 1) in force since 1 September 2024 (Module 1 and 2)

The marketing authorisation of medicinal products for human use (HMP) requires an environmental risk assessment (ERA). It is based on the maximum daily dose (MDD), the physico-chemical, ecotoxicological, and fate properties of its active substance(s). Numerous changes and new features arise from the revision, e. g., with regard to the test strategies to be used (e. g., antibiotic agents), the assessment of possible secondary poisoning and the methodology. The guideline is significantly more comprehensive and the requirements are more stringent. It provides a detailed overview of the assessment using a decision tree. The reform of European pharmaceutical law is intended to support the goals of the European Green Deal, which calls for a transformation of the economy and society towards more environmental protection and sustainability. This means that environmental aspects may lead to the rejection of a marketing authorisation. Our online seminar provides a detailed explanation for the preparation of ERAs according to the revised guideline. New features are addressed and the impact they have on your ERA. The online seminar is separated into 2 modules. The seminar will be held in English.

Zielsetzung

This online seminar provides introductory insights in the ERA of human medicinal products (non-GMOs) according to the EMA or FDA guideline and show differences in the procedure (e.g., exposure calculation). Both methodologies follow a tiered approach based on the results of tests on fate and effects.

Preishinweis

Preis inkl. MwSt.