Analysis of the relationship between safety concerns in RMP at the time of drug approval and addition to clinically significant adverse reaction in the package inserts after approval

○Rieko Saito

9:00 AM - 10:40 AM

[27PO7-am1-08] Analysis of the relationship between safety concerns in RMP at the time of drug approval and addition to clinically significant adverse reaction in the package inserts after approval

○Rieko Saito¹, Nanae Uno¹, Yuki Kobayashi¹, Eri Hasegawa¹, Seiko Miyazaki¹ (1. Showa Pharmaceutical Univ.)

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Presentation information

[27PO7-am1] Regulatory sciences (pharmaceuticals, etc.)-2

[27PO7-am1-08] Analysis of the relationship between safety concerns in RMP at the time of drug approval and addition to clinically significant adverse reaction in the package inserts after approval

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