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