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Date: Thursday, August 20, 2026

Time: 3:00 pm – 4:00 pm, Korea time

Summary

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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Key learning objectives:

  • Explore how Pinnacle 21 Enterprise helps review and validate SEND data with an FDA-trusted solution, supporting high-quality and compliant regulatory submissions
  • Discover how SEND Explorer enables efficient analysis and visualization of GLP toxicology data to gain deeper insights throughout the nonclinical development process
  • Learn practical strategies and case studies for preparing nonclinical SEND data to support successful global regulatory submissions and market entry

This webinar is ideal for:

This webinar is designed for professionals involved in nonclinical development, regulatory submissions, and data management, including:

  • Nonclinical scientists and toxicologists
  • Regulatory affairs professionals
  • Bioinformatics and data science teams
  • Pharmaceutical and biotechnology professionals responsible for regulatory submissions

Speakers:

Heeyoung Kim

Director, APAC Solution Consultant Team

Heeyoung 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.

Register now