Online Seminar “Environmental risk assessment of medicinal products for human use” according to revised EMA guideline (EMEA/CHMP/SWP/4447/00 Rev. 1) coming in force in September 2024
Module 1: 18.09.2024, 08:30 a.m. – 11:45 a.m.
Module 2: 19.09.2024, 08:30 a.m. – 11:45 a.m.
Seminar language: German
Numerous changes and extended requirements result from the revision of the guideline, e.g., with regard to data requirements, test strategies (especially for antibiotics), the assessment of possible risks due to bioaccumulation in the environment and the methodology to be used.
The increasing importance of environmental considerations is also evident in the draft of the revised Medicinal Products Directive 2001/83/EC, which takes into account the objectives of the European ‘Green Deal’ for greater environmental protection and sustainability. A ‘lifecycle’ assessment of medicinal products is also required from an environmental point of view.
This online seminar is divided into two modules (which can be booked individually and together) and is practice-orientated. The focus is on the preparation of ERAs based on the revised guideline with its many new features.
Module 1: Legal framework, data analysis and introduction to environmental risk assessment
| Zeit (CE(S)T) | Thema |
| 08:30 – 10:00 | Introduction and overview of the revised Directive 2001/83/EC with reference to the environment Principles and overview of the revised ERA Guideline EMEA/CHMP/SWP/4447/00 Rev. 1 |
| 10:00 – 10:15 | Break |
| 10:15 – 11:45 | Data analysis ERA Assessment Phase-I PBT screening and assessment |
Module 2: Phase-II strategy and extended environmental risk assessment
| Zeit (CE(S)T) | Thema |
| 08:30 – 10:00 | Compartment-specific Phase II assessment, Part 1: Physico-chemical properties, fate in the environment, ecotoxicity, exposure action values |
| 10:00 – 10:15 | Pause |
| 10:15 – 11:45 | Compartment-specific Phase II assessment, Part 2: Surface water, sediment, wastewater, soil, groundwater ERA-Template Module 1.6.1 Summary; Q&A |
In cooperation with 
