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: 4 November 2025; 09:00 a.m. – 12:15 p.m. (CET)
Day 2: 5 November 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, CTD Module 1.6.1). It is based on the maximum daily dose (MDD) and depends on the physico-chemical, ecotoxicological, and fate properties of the 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 and a decision tree for Phase I.
The Online Seminar provides a detailed explanation for the preparation of ERAs according to the revised guideline. New features and the impact they have on preparation of ERA are addressed.
The seminar will be held in English.
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. – 10:00 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 – Changes to former guideline |
| 10:00 a.m. – 10:15 a.m. | Break |
| 10:15 a.m. – 12:00 p.m. | ERA guideline EMEA/CHMP/SWP/4447/00 Rev. 1 – Phase I and PBT assessment – Database search and requirements on data quality |
| 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 1: Physico-chemical properties, fate, ecotoxicity, trigger values; |
| 10:30 a.m. – 10:45 a.m. | Break |
| 10:45 a.m. – 12:00 p.m. | Part 2: Compartment specific Phase II assessment and changes to former guideline ERA Module 1.6.1 template Overview over study costs and timeline; Final discussion and Q & A |
Contact
ACA-pharma concept GmbH
Telefon: +49 (0) 341-223 292 36
Email: aca_campus@aca-pharma.eu
