María José Villarroel

Toxicology & Quality Director at QbD Group · Toxicology & Quality Director

4 articles

ToxicologyQuality AssuranceApr 1, 2026 7 min

Extractables and Leachables (E&L): Reviewing the Current Regulatory Landscape

Extractables and leachables requirements are evolving with draft ICH Q3E. Learn how companies can prepare for future E&L regulatory expectations.

Regulatory AffairsFeb 25, 2026 2 min

EMA Framework for the Qualification of Non-Mutagenic Impurities

The European Medicines Agency (EMA) has adopted a Reflection Paper on the Qualification of Non-Mutagenic Impurities (EMA/CHMP/4299/2026), introducing a new scientific framework for the safety assessment of non-mutagenic impurities in medicinal products.

ToxicologyOct 27, 2025 6 min

Environmental Risk Assessments (ERA) in Pharma: Balancing Health & Environment

Explore how Environmental Risk Assessment (ERA) helps ensure medicines heal us without harming the planet, balancing healthcare advances with ecological preservation.

Apr 23, 2024 1 min

New EMA Guideline on Environmental Risk Assessment for Human Medicinal Products

New guideline from the European Medicines Agency (EMA) on the Environmental Risk Assessment of medicinal products for human use, accepted on February 15 and set to come into effect on September 1, 2024, stipulates that an ERA report will be required for all new applications for marketing authorization of medicinal products for human use.

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