2023³â ICH °¡À̵å¶óÀÎ ±³À° Day 2 - Safety&Efficacy ÀÚ·áÁýÀÔ´Ï´Ù.
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#1_[S5(R3)] À¯¿íÁØ (¾ÈÀü¼ºÆò°¡¿¬±¸¼Ò): ICH S5(R3) (2020.2.18) ÀǾàÇ°¿¡ ´ëÇÑ »ý½Ä¹ß»ýµ¶¼º ½ÃÇè °¡À̵å¶óÀÎ
#3_[S1B(R1)] Kenjiro Tsubota (Astellas Pharma Inc.): Case examples – What Products Enable us to Request a Waiver?
#4_[E2B(R3)] Denny Lorenz (Bayer AG): ICH E2B(R3) Clinical Safety Data Management: Data Elements for Transmission of ICSRs
#5_[E2B(R3)] ÀÌÁ¤¹Î (LSK±Û·Î¹úÆĸ¶¼ºñ½º): ICH E2B(R3)ÀÇ ÀÌÇØ¿Í Çѱ¹ÀÇ °¡À̵å¶óÀÎ
#6_[E6(R2)] ±è¼ºÀº (»çÀÌŬ·è½º): ICH E6(R2) °¡À̵å¶óÀÎ Àû¿ë »ç·Ê
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¹®ÀÇ : edu@kobia.kr