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Environmental risk assessment (ERA) of medicinal products for human use

This online seminar provides introductory and comparative insights in the ERA of human medicinal products (non-GMOs) based on the regularoty requirements according to EMA and FDA. With focus on the EMA Guideline the preparation of an ERA is explained more detailed.

01&02.04.2025 from EUR 690.00

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

Our online seminar explains the numerous changes and extended requirements resulting from the revision of the EMEA/CHMP/SWP/4447/00 guideline. This online seminar is divided into two modules and is practice-orientated. The focus is on the creation of ERAs based on the revised guideline with its many new features.

Module 1: Legal framework, data analysis and introduction to environmental risk assessment
Module 2: Phase II review strategy and extended environmental risk assessment

Seminar language: German

tba from EUR 530.00
Evaluation & qualification of impurities in small molecule drug substances and products, cleaning validation, leachables and extractables (E&L) upon request
CBD-Produkte und THC-Gehalt: Gesetzeslage und Sicherheitsaspekte upon request

For further information on our seminars on medicinal products please contact:

Bianca Leubner
phone: +49 (0) 341-223 292 36
E-Mail: ACA_Campus@aca-pharma.eu

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