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From Data to Submit: Considerations of CDISC Compliance for Global Regulatory Submissions [Korean Webinar]

Thu, June 27th 2024
録画ウェビナー

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Dataset from clinical trials must comply with CDISC standards for a regulatory review. In this webinar, Eunhee Lee, Associate STAT Director of LSK Global PS, who has deep experiences with CDISC standardization in Korea, will share the latest status and insights of CDISC standardization in Korea. Together with our guest speaker, we will also walk through new features and global trends in Pinnacle 21 Enterprise to validate SDTM/ADaM datasets that will be submitted and reviewed with the same perspectives with regulators.  

こんな方におすすめなウェビナーです: 

  • CDISC experts in the pharmaceutical companies 
  • CROs 

講演者  

  • Eunhee Lee, Ph.D, Associate STAT Director of LSK Global PS
  • Heeyoung Kim, Manager of Solution Consultants APAC, Certara 
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