EMA Revised ERA Guideline: Practical Insights One Year On

In February 2026, ProductLife Group will host a focused webinar dedicated to the practical application of the revised EMA Environmental Risk Assessment (ERA) guideline, one year after its implementation.

As organisations continue to adapt to the expanded scope of the guideline, many teams are still facing questions around tiered Phase I and Phase II requirements, data expectations, and how to ensure ERA submissions remain robust, consistent and compliant across development programmes.

This 25-minute session draws on real-world regulatory interactions and ERA projects conducted throughout 2025, offering practical insights to help regulatory and non-clinical teams navigate this evolving landscape with confidence.

What the webinar will cover

• Key lessons learned from implementing the revised ERA guideline in practice
• Common challenges observed across both generic and innovative products
• Strategies to strengthen ERA reporting, manage agency feedback and mitigate regulatory risk
• Guidance on letter-of-access expectations and oversight of partner laboratories

Speakers

Amit Salvi | Regulatory Consultant - Non Clinical & Clinical Development

Vishnu Jatoth | Regulatory Toxicologist - Non Clinical Development

Practical information

5 February 2026 | 11:00 CET

Format: Free online webinar held in English

Register here