QbD Group
    Upcoming Webinar

    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.

    Thursday, May 28, 2026
    4 PM CET / 3 PM GMT
    Quality Assurance
    English

    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

    Learn from the best

    Speakers

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

    Natalia Herrera

    Natalia Herrera

    Global Toxicology Liaison, QbD Group

    Natalia holds a PhD in Pharmacy and a Master's degree in Drug Research, Development and Innovation. With a strong background in business development her career also includes outstanding contributions as Medical Sales Representative in different companies, such as Abbott. In addition, Natalia has valuable experience in quality assurance from her time at Pfizer and other pharmaceutical manufacturing sites, ensuring compliance with industry standards.
    Mae Ann Belandres

    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.

    Is this for you?

    Who should attend?

    This webinar is designed for professionals involved in regulatory, toxicology, and development activities within pharmaceutical companies, particularly those responsible for preparing or supporting regulatory submissions.

    Regulatory Affairs (RA) professionals involved in marketing authorization applications and lifecycle management

    Tech Transfer professionals supporting product and process transitions

    QA, toxicology, and non-clinical experts responsible for environmental risk assessments

    CMC and development teams involved in data generation and submission strategies

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