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[ICH 2019] Quality Program(9/4) з
û 2019.08.06~2019.08.28 2019.09.04~2019.09.04
׷ư, Ȧ ð 9:30-18:00
÷ ICH 2019_Program_KoBIA_0826.pdf

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9 4, ׷ư Ȧ(4F)

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9:30 - 9:40 (10') 
Opening Speech / ȯ
NIFDS
9:50 - 10:10 (20') 
ICH Guideline and new drug development 
ICH ̵ΰ žళ
Hoonjoo Kim(President, Daegu-Gyeongbuk Medical Innovation Foundation)
ICH Q6 A/B : Specification
10:10 - 11:20 (70') 
Compliance with the specifications for the global expansion of biologic medicines
̿Ǿǰ ۷ι ԰ ؼ
Jae-woong Hwang (Director, Samsung Bioepis)
11:20 - 12:30 (70') 
Health Canadas experience with the application of ICH Guidelines on Specifications for Biotechnological/Biological Products
ICH ؿ ٰ コij ̿Ǿǰ 㰡ɻ
Hugo Hamel (Senior Reviewer, Health Canada)
ICH Q1 A(R2)/D : Stablity
14:00 - 15:10 (70') 
Experience in Implementing ICH Stability Guidelines Q1A(R2) and Q1D with Case Studies
ʷ ICH ̵(Q1A(R2), Q1D) 
Chi-wan Chen (Executive Director, Pfizer Inc)
ICH Q5 A(R1)/B/D : Biopharmacecuticals
15:10 - 16:20 (70') 
Health Canadas experience with the application of ICH Guidelines on Viral Clearance for Biotechnological/Biological Products
̿Ǿǰ ̷ ̵
Christopher Storbeck(Senior Reviewer, Health Canada)
16:20 - 16:40 (20')  Coffee Break
16:40 - 17:50 (70') 
Quality of Biotechnological Product: Analysis of Expression Construct(Q5B) and Derivation/Characterization of Cell Substrates(Q5D)
ǰ ǰ: 'Expression Construct' м(Q5B) 'Cell Substrate' ó/Ư Ȯ(Q5D)
Myongjin Kim (Director, Celltrion)
17:50 - 18:00 (10')  Closing
2019 ICH ̵
  • Ͻ: 9 4() 9:30 - 18:00
  • : ׷ư ޶Ȧ(3F)

  • M3(R2): Nonclinical Safety Studies 
    M7(R1): Assessment and Control of Mutagenic Impurities 

  • Ǿб, GSK, ƿƼ, AstraZeneca  and more! 
  • Ͻ: 9 5() 10:00 - 17:50
  • : ׷ư ޶Ȧ(3F)

  • S3A/B:  
    S7A/B: QT/QTc , ฮ

  • Health Canada, PMDA, 
    򰡿, Ǿб and more! 
  • Ͻ: 9 5() 9:30 - 18:00
  • : ׷ư Ȧ(4F)

  • E2A/E2B(R3): Clinical Safety Data Management 
    E9: Statistical Principles for Clinical Trials  

  • FDA, Dmed, PMDA, MFDS, PVCON 
    and more! 
[] NIFDS-DIA  
ICH Workshop on PV
- 2019 9 6() 
- ׷ư,
* Early Bird ֽϴ *
* û α׷ û ȳ ȮϽñ ٶϴ. *

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  • û 8 28() ˴ϴ.
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  • Ȱ  ϰ ϴ   ûϿ ֽñ ٶϴ.
Quality & Safety
KoBIA(ѱ̿Ǿǰȸ)
ȫ edu@kobia.kr / 02-725-8431
Multidisciplinary & Efficacy
KRPIA(ѱ۷ιǾȸ)
hyein@krpia.or.kr / 02-501-2923
2019 ICH ̵  Ʈ ֽ α׷ Ϸ ް е KoBIA ͸ ֽñ ٶϴ. [Click]

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