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ICH Q12Ǿǰ ֱ ס ̵() ǰȸ
  • ۼ 2018-03-19 16:30:32
  • ȸ 11235
÷ ICH Q12.zip

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 ÷





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2. Q12 Ǿǰ ֱ η()
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