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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.

Quality Assurance Pharma & Biotech Environmental Risk Assessment Regulatory Affairs Toxicology

随时观看

60 分钟

Quality Assurance

中文

Contents

Chapters

00:00Introduction
03:22ERA in context: regulatory framework and submission challenges
13:04From data to decision: building a submission-ready ERA
41:31Case study: from assessment to regulatory acceptance
45:55Q&A

Complete Your Environmental Risk Assessment

Assess the environmental profile of your pharmaceutical products with our detailed report. Identify and mitigate the environmental risks.

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.

您将学到什么

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

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演讲者

Two toxicology experts at QbD Group with deep regulatory and scientific experience supporting environmental risk assessments for pharmaceutical submissions.

Natalia Herrera

Sales Specialist Toxicology, QbD Group

Natalia holds a PharmD and a Master's degree in Drug Research, Development and Innovation. With a strong background in business development, her career also...

Mae Ann Belandres

Senior Consultant Toxicology, QbD Group

Mae Ann holds a Bachelor of Science in Chemistry and brings nearly two decades of experience in toxicology, product development, and regulatory compliance. Her technical expertise is backed by specialized training in assessing substances under the EU REACH Regulation (EC) No 1907/2006, including the preparation of technical reports on environmental fate, properties, and risk potential. She has extensive experience conducting environmental risk assessments, currently serving as a Senior Consultant in Toxicology at QbD Group.

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