Online Seminar “Environmental risk assessment of medicinal products for human use” according to revised EMA guideline (EMEA/CHMP/SWP/4447/00 Rev. 1) in force since 1 September 2024
Day 1: 1 April 2025; 09:00 a.m. – 12:15 p.m. (CEST)
Day 2: 2 April 2025, 09:00 a.m. – 12:00 p.m. (CET)
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.
Agenda of the Online Seminar
| Time (CE(S)T) | Topic |
| 08:30 a.m. – 09:00 a.m. | Welcome & Log in |
| 09:00 a.m. – 10:15 a.m. | Legal basis of the Environmental Risk Assessment (ERA) of medicinal products for human use ERA guideline EMEA/CHMP/SWP/4447/00 Rev. 1 – Principles and Overview – ERA guideline EMEA/CHMP/SWP/4447/00 Rev. 1 – Phase I and PBT assessment – |
| 10:15 a.m. – 10:30 a.m. | Break |
| 10:30 a.m. – 12:15 p.m. | Definitive PBT assessment Requirements on data quality Compartment specific Phase II assessment, Part 1: Physico-chemical properties, fate, ecotoxicity, trigger values; changes to former guideline |
| Time (CE(S)T) | Topic |
| 08:30 a.m. – 09:00 a.m. | Welcome & Log in |
| 09:00 a.m. – 10:30 a.m. | Compartment specific Phase II assessment, Part 2: Surface water, sediment, sewage treatment, soil groundwater; changes to former guideline ERA Module 1.6.1 template |
| 10:30 a.m. – 10:45 a.m. | Break |
| 10:45 a.m. – 12:00 p.m. | Overview over study costs and timeline; Final discussion and Q & A |
The seminar will be held in English. If you are interessted in our Online Seminar please us.
Contact
ACA-pharma concept GmbH
Telefon: +49 (0) 341-223 292 36
Email:
