Online Seminar “Environmental risk assessment of medicinal products for human use” according to the revised version of the EMA guideline
tbd, 9:00 – 15:00 (CE(S)T)
It is mandatory for a marketing authorisation application (MAA) for a medicinal product for human use (HMP) to include an environmental risk assessment (ERA). This ERA is based on the use of the product and the physico-chemical, ecotoxicological, and fate properties of its active substance(s). From September 2024, the assessment has to be conducted according to the revised version of the “Guideline on the environmental risk assessment of medicinal products for human use” from the European Medicines Agency (EMA).
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.
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
| 08:45 | Opening of the waiting room |
| 09:00 – 09:30 | Introduction and General overview of ongoing ERA process in context with “green deal” |
| 09:30 – 10:00 | General Principles and Overview of the ERA according to the new guideline EMEA/CHMP/SWP/4447/00 Rev. 1 |
| 10:00 – 11:00 | Phase I and PBT screening |
| 11:00 – 11:15 | Break |
| 11:15 – 12:15 | Compartment specific Phase II risk assessment according to the new guideline EMEA/CHMP/SWP/4447/00 Rev. 1 (Part 1: physico-chemical properties, fate, ecotoxicity, trigger values) and changes to former guideline |
| 12:15 – 13:15 | Break |
| 13:15 – 14:15 | Compartment specific Phase II risk assessment according to the new guideline EMEA/CHMP/SWP/4447/00 Rev. 1 (Part 2: surface water, sediment, sewage treatment, soil groundwater) and changes to former guideline |
| 14:15 – 14:45 | PBT assessment |
| 14:45 – 15:00 | Template for ERA report |
| 15:00 – 15:20 | Summary; Q & A |
The presentations are held in English. There will be time to answer your questions.
Contact
ACA-pharma concept GmbH
Telefon: +49 (0) 341-223 292 36
E-Mail: aca_campus@aca-pharma.eu
