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

Arzneimittel

Unsere Veranstaltungen

Seminar Datum Kosten

Umweltrisikobewertung von Humanarzneimitteln gemäß der überarbeiteten EMA-Leitlinie (EMEA/CHMP/SWP/4447/00 Rev. 1), die im September 2024 in Kraft tritt

Unser Online-Seminar erläutert die zahlreichen Änderungen und erweiterte Anforderungen die sich aus der Überarbeitung der Guideline EMEA/CHMP/SWP/4447/00 ergeben. Dieses Online-Seminar ist in zwei Module unterteilt und praxisorientiert ausgerichtet. Der Schwerpunkt liegt auf der Erstellung von ERAs anhand der revidierten Guideline mit den vielfältigen Neuerungen.

Modul 1: Rechtliche Rahmenbedingungen, Datenanalyse und Einführung in die Umweltrisikobewertung
Modul 2: Phase-II-Prüfstrategie und erweiterte Umweltrisikobewertung

 18.09.2024 &
19.09.2024		 ab 530,00 €

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.

 Inhouse remote seminar auf Anfrage
Evaluation & qualification of impurities in small molecule drug substances and products, cleaning validation, leachables and extractables (E&L) auf Anfrage
CBD-Produkte und THC-Gehalt: Gesetzeslage und Sicherheitsaspekte auf Anfrage

Archiv

Online Workshop: CBD-Produkte und THC-Gehalt: Gesetzeslage und Sicherheitsaspekte am 24.09.2020

Seminar – “Evaluation & qualification of impurities in small molecule drug substances and products, cleaning validation, leachables and extractables (E&L)”, 05/06.02.2020 in Leipzig

Seminar – “Aktuelle Fragen zur Arzneimittelsicherheit”, 26/27.09.2017 in Leipzig

Seminar – “Aktuelle Fragen zur Arzneimittelsicherheit”, 28./29. September 2016 in Leipzig

Seminar – “Reinigungsvalidierung”, 05. April 2016 in Aachen

Seminar – “Verunreinigungen in Arzneimitteln”, 22. Oktober 2015

Seminar – “Reinigungsvalidierung”, 05. Februar 2016 in Dresden

Seminar – “Verunreinigungen in Arzneimitteln”, 11. September 2014

Seminar – “Umweltverträglichkeitsprüfung (ERA) für Human- und Tierarzneimittel”, 11. November 2011

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