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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.

Individual Inhouse Online seminar upon request

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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