aca24@aca-pharma.de/ +49 341 223 292 36

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
(1-Day Individual Inhouse Seminar)

04.09.2024 (for America: 01:30 p.m. – 08:00 p.m. (CEST)) or
on request

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./
01:30 p.m. – 02:00 p.m.
Welcome & Log in
09:00 a.m. – 10:30 a.m./
02:00 p.m. – 03:30 p.m.
Principles and overview of revised ERA Guideline EMEA/CHMP/SWP/4447/00 Rev. 1
Data analysis
ERA Assessment Phase I
10:30 a.m. – 10:45 a.m./
03:30 p.m. – 03:45 p.m.
Break
10:45 a.m. – 12:45 p.m./
03:45 p.m. – 05:45 p.m.
PBT screening and assessment
Compartment specific Phase II risk assessment according to the revised guideline: Part 1: Physico-chemical properties, fate, ecotoxicity, trigger values; changes to former guideline
12:45 p.m. – 01:15 p.m./
05:45 p.m. – 06:15 p.m.
Break
01:15 p.m. – 02:45 p.m./
06:15 p.m. – 07:45 p.m.
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
02:45 p.m. – 03:00 p.m./
07:45 p.m. – 08:00 p.m.
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 contact us.

Contact
ACA-pharma concept GmbH
Telefon: +49 (0) 341-223 292 36
Email: aca_campus@aca-pharma.eu

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