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SEND datasets have become an integral part of the review, analysis, and interpretation of nonclinical toxicology studies as per FDA guidance and the needs and trend will only continue to grow. The SEND dataset creation process is challenging and often requires a combination of data integration and manual effort. The quality control process is critically essential to ensuring that SEND dataset packages are fit for use.
Certara provide solutions to solve your challenge of SEND dataset QC for FDA submissions. We will invite a guest speaker from Korea Institute of Toxicology (KIT) and discuss below with Certara’s experts in Korea.
- Recommendations for SEND Dataset QC Best Practice (From PHUSE)
- FDA SEND dataset review process by Pinnacle 21 Enterprise
注記：The webinar will be available only in Korean.
講演者：
Yunki Kim, Senior researcher, Korea Institute of Toxicology
Heeyoung Kim, Solutions Consultant, Certara Korea
