Environmental Risk Assessments (ERA) From Regulatory Requirements to Submission-Ready Strategies
Understand how to translate ERA regulatory expectations into a robust, science-based and submission-ready approach. Learn how to avoid common pitfalls, optimize data requirements and build a defensible Environmental Risk Assessment aligned with current regulatory expectations.
Environmental Risk Assessments (ERA) have become a critical component of regulatory submissions for pharmaceutical products, both at the time of marketing authorization and throughout the product lifecycle. While regulatory expectations are well defined, many organizations still face challenges when translating these requirements into efficient, scientifically sound and submission-ready assessments.
This webinar provides a structured and practical perspective on ERA, combining regulatory context with real-world implementation strategies. It will explore why ERA often becomes a bottleneck in submissions, how to design an effective risk assessment approach, and how to ensure that the final output meets regulatory expectations without unnecessary studies or delays.
Building on regulatory expectations and real-world insights, the session explores ERA challenges, technical approaches, and practical strategies to support submission-ready outcomes.
What you'll learn
- The role of ERA in marketing authorization applications and lifecycle management
- Why ERA often becomes a bottleneck in submissions and how to avoid common pitfalls
- How to structure a robust and science-based ERA aligned with EMA and international guidelines
- Key technical components of ERA, including PEC calculation, PNEC derivation, and risk characterization
- How to define data requirements and justify waivers to avoid unnecessary studies
- What regulators expect in a submission-ready ERA and how to ensure compliance
- How to apply these concepts in practice through real case scenarios