Environmental Risk Assessment for Human Pharmaceuticals What Changed with the Updated EMA ERA Guideline (Rev.1) and the EU Pharmaceutical Package?

Presented at SETAC Europe 2026 in Maastricht, this presentation by ibacon GmbH, explores the latest updates to the Environmental Risk Assessment (ERA) framework for human pharmaceuticals under the revised EMA Guideline (Rev.1) and the upcoming EU Pharmaceutical Package.

The presentation covers the new regulatory expectations for pharmaceutical companies, including updated ERA requirements, hazard and risk assessment approaches, study requirements and tailored testing strategies for specific substance groups such as endocrine active substances and antibacterials.

Presentation details
Title: Environmental Risk Assessment for Human Pharmaceuticals – What Changed with the Updated EMA ERA Guideline (Rev.1) and the EU Pharmaceutical Package?
Presenter: Sabine Schwientek, Business Development Manager, ibacon GmbH
Event: SETAC Europe 2026 – Maastricht

The presentation slides are available for download as a PDF.