临床安全性总结（SCS）-综合安全性总结（ISS）开发.pdfVIP

Summary of Clinical Safety(SCS)/ Integrated Safety Summary(ISS) Development Chen Huang Roche Product Development Safety © 2021 DIA, Inc. All rights reserved. Page 2 Disclaimer /免责声明 © 2021 DIA, Inc. All rights reserved. Content Regulations and Guidance Safety Review Safety Strategy for NDA/BLA Summary QA © 2021 DIA, Inc. All rights reserved. Regulations and Guidance ICH M4 Organis