WEBINAR - Navigating the EMA’s Revised ERA Guideline: Key Insights One Year Later

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.

During the session, PLG experts will share:

• 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

Whether you are refining your ERA strategy or preparing marketing authorisation applications, this webinar is designed to bring clarity to regulatory expectations and support more effective, future-proof ERA submissions.

Amit Salvi | Regulatory Consultant – Non Clinical & Clinical Development

Vishnu Jatoth | Regulatory Toxicologist – Non Clinical Development

🗓️ 5 February 2026 | 🕒 11:00 CET

📍 Format: Free online webinar held in English