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
(Individual Inhouse Seminar)
Day 1: 08:30 – 11:45 a.m. (CE(S)T)
Day 2: 08:30 – 11:45 a.m. (CE(S)T)
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 – 10:00 | Introduction and overview of revised Directive EC 2001/83 concerning environment Principles and overview of revised ERA Guideline EMEA/CHMP/SWP/4447/00 Rev. 1 |
| 10:00 – 10:15 | Break |
| 10:15 – 11:45 | Data analysis ERA Phase I assessment PBT screening and assessment |
| Time (CE(S)T) | Topic |
| 08:30 – 10:00 | Compartment specific Phase II risk assessment according to the revised guideline: Part 1: Physico-chemical properties, fate, ecotoxicity, trigger values; changes to former guideline |
| 10:00 – 10:15 | Break |
| 10:15 – 11:45 | Compartment specific Phase II risk assessment according to the revised guideline: Part 2: Surface water, sediment, sewage treatment, soil groundwater; changes to former guideline ERA template Summary; Q&A |
The seminar will be held in English and customised to your individual needs. If you are interessted in our individual Online Seminar please us.
Contact
ACA-pharma concept GmbH
Telefon: +49 (0) 341-223 292 36
