ѱ̿Ǿǰȸ ȳ帳ϴ.
ICH ȸ(Expert Working Group) ǵ ICH Q12Ǿǰ ֱ ̵() ü ǰ ϰ ֽϴ.
̿ ǰǾǰ ̵() Ͽ úμ ôü ǰ ϰ Ͽ, ǰ ִ 18.10.25() ǰ ۼϿ 츮ȸ(johs8739@kobia.kr) Ͽ ֽñ ٶϴ.
[ICH Q12 Ǿǰ ֱ ] | |
|
ֿ䳻 : 1. ̵ • 㰡 CMC û з(Categorisation of Post-Approval CMC Changes) • (Established Conditions, ECs) • 㰡 ȹ(Post-Approval Change Management Protocol, PACMP) • ǰ ֱ (Product Lifecycle Management, PLCM) • Ǿǰ ǰ ý (Pharmaceutical Quality System(PQS) And Change Management) • 籹 (Relationship between Regulatory Assessment and Inspection) • ǰ 㰡 (Post-Approval Changes for Marketed Products)
2. η • (ECS-Illustrative Examples) • PACMP (PACMP-Illustrative Examples) • ǰ ֱ (Product Lifecycle Management-Illustrative Examples) ڼ ÷ |
մϴ.[÷]1. Q12 Ǿǰ ֱ () 2. Q12 Ǿǰ ֱ η() 3. Q12 Ǿǰ ֱ () ()4. Q12 Ǿǰ ֱ η() () 5. ǰ .