概述
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.
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