Date: Thursday, August 20, 2026
Time: 3:00 pm – 4:00 pm, Korea time
Services: Biometrics and Data Science Services
Products: Pinnacle 21®, SEND Explorer®
Summary
The webinar will be delivered only in Korean
As regulatory expectations for standardized nonclinical data continue to evolve, the ability to efficiently prepare, review, and analyze SEND datasets has become essential for successful global submissions.
In this webinar, Certara and Biotoxtech experts will share practical strategies and actual cases for managing SEND data throughout the regulatory submission journey.
Learn how Pinnacle 21 Enterprise, the FDA’s solution for SEND validation and compliance, helps organizations ensure data quality and submission readiness. Discover how SEND Explorer enables efficient review and analysis of GLP toxicology data within an environment trusted by regulatory agencies.
Through expert presentations and case studies, this session will provide insights into preparing nonclinical SEND data for global market entry and maximizing the value of standardized data.
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Heeyoung Kim
Director, APAC Solution Consultant TeamHeeyoung Kim has over 17 years of experience in the clinical industry, contributing significantly to advancements in drug development. As a trusted advisor, her career reflects a commitment to enhancing the drug development lifecycle through innovative solutions and effective communication of industry trends. Her primary focus is identifying gaps between the current state and the industry’s goals, then finding solutions to achieve unmet targets. She influences market stakeholders to better understand new global trends and regulatory updates. Looking ahead, Heeyoung aims to continue improving drug development processes by introducing new technical insights and methodologies to advance the industry.
Director, Sales & Marketing Division, Biotoxtech Co., Ltd.
Hye-Yeong Lee brings over 24 years of expertise to the non-clinical and toxicity evaluation industry, with a career built on advancing safe and scientifically sound drug development. As a Certified Toxicologist with the Korean Society of Toxicologists, she has held progressively strategic roles at Biotoxtech Co., Ltd. — from Study Director of general toxicity studies, to Operations Manager, to leading the introduction of new toxicity programs. As a trusted expert in the field, she now focuses on Biotoxtech’s SEND initiatives, working to close the gap between evolving regulatory data standards and practical industry implementation. Looking ahead, she aims to continue advancing non-clinical data practices by introducing new methodologies and strengthening alignment with global regulatory expectations.
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