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2019 ICH ̵ (9/4~5) з
û 2019.08.26~2019.08.28 2019.09.04~2019.09.05
׷ư ð 9:00 - 18:00
÷ ICH 2019_Program_KoBIA_0826.pdf | KRPIA_ich.jpg

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9 4 - 5, ׷ư

* 2019 ICH ̵  ûϽ е鲲 ϰ ߼  Դϴ.
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* Ʒ α׷ 2  PCȭ鿡 ȭ Ǿ ֽϴ.
* ʷ ȸ Ȩ ȮϽ ֽϴ.
[Day 1] 9 4()
Q: ׷ư 4 Ȧ 
M: ׷ư 3 ޶Ȧ 
9:30 - 9:40 (10')
Opening Speech
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9:50 - 10:10 (20') 
ICH Guideline and New Drug Development
ICH ̵ Ȳ
DGMIF
9:50 - 11:00 (70') 
ICH M3(R2): Nonclinical Safety Studies for IND and NDA    
Donghwan Kim (KYU)
10:10 - 11:20 (70') 
Compliance with the specifications for the global expansion of biologic medicines
̿Ǿǰ ۷ι ԰ؼ
Ȳ Z̿ǽ ׷
11:20 - 12:30 (70') 
ICH M3(R2) Questions and answers (Q&A) with case studies    
Richard Haworth (GSK)
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 (Health Canada)

LUNCH
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 (Pfizer)
14:00 - 15:20 (80') 
General Principles of ICH M7    
Joomi Kim (Dong-A ST)
15:10 - 16:20 (70') 
Health Canadas experience with the application of ICH Guidelines on Viral Clearance for Biotechnological/Biological Products 
̿Ǿǰ ̷ ̵
Christopher Storbeck (Health Canada)
15:40 - 17:00 (80') 
ICH M7 Addendum: Derivation of compound-specific acceptable intakes/ Permissible Daily Exposures for impurities in pharmaceuticals    
Patricia Parris (AstraZeneca)
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)
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[Day 2] 9 5()
S: ׷ư 3 ޶Ȧ 
E: ׷ư4 Ȧ 
10:00 - 11:10 (70') 
Understanding and Applying Toxicokinetics in Drug Development
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Ȳ Ǿб
09:30 - 10:30 (60')   
Implementation of E2B(R3)  
Yukie Yamaguchi (PMDA)    
11:30 - 12:40 (70') 
An overview of ICH S3 guideline questions and answers
ICH S3A QnA ؼ  PMDA 㰡ɻ
Jihei Nishimura (PMDA)
10:50 - 11:50 (60')   
ICH E2B(R3) Guideline of China 
Stella Xu (Dmed)    
LUNCH
14:00 - 15:10 (70') 
Introduction of Safety Pharmacology and Basic Mechanism of TdP and QT Interval Prolongation
ฮ ؿ QT 忡 ߻ ̷
KIT յ
13:20 - 14:00 (40')   
ICH E2B(R3) Implementation in Korea
Yubin Lee (MFDS)

14:00 - 15:00 (60')   
ICH E2A – Clinical Safety Data Management: Definitions and Standards for Expedited Reporting
Gerald Dal Pan (FDA)
15:30 - 16:50 (70') 
A Regulatory Perspective on Implementation of the ICH S7B and E14 Guidelines on the Non-Clinical and Clinical Evaluation of QTc Prolongation Potential
ICH S7B E14 ̵ο  QTc  忡 ӻӻ 򰡻
Colette Strnad (Health Canada)
15:20 - 16:20 (60')   
Inspection Readiness Through Internal Audits
Moin Don (PVCON)

16:20 - 17:20 (60')   
A summary of the key messages in ICH E9, an introduction to Estimands and the Addendum to ICH E9
David Wright (AstraZeneca)
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α Ĵ & ȳ
  • 򰡿 ICH ̵ (9/4~5) ߽ ʽϴ.
  • ȣ , Ʈ ڸ 20% ˴ϴ. (߽Ĵ, ī )
  • α Ĵ ޴ ġ ȳ ൵ Ͻñ ٶϴ.

ڱ û ȳ 
  • / ̸, 뿪 ˴ϴ.
  • Google Survey е QRڵ带  Ϸ Ͻñ ٶϴ.
  • Ȱ  ϰ ϴ   ûϿ ֽñ ٶϴ.
  • ¶ û (8 28()) Ŀ մϴ.
  • ûڸ 켱 ȹԴϴ.
  • α׷ KoBIA Ȩ ÷ ȮϽñ ٶϴ.
[BtoB] 9 6()
[] NIFDS-DIA  
ICH Workshop on PV
Ͻ: 2019 9 6() 
: ׷ư,
* Early Bird ֽϴ.  û α׷ û ȳ ȮϽñ ٶϴ. *
[ ]
Quality & Safety
KoBIA(ѱ̿Ǿǰȸ)
ȫ edu@kobia.kr / 02-725-8431
Multidisciplinary & Efficacy
KRPIA(ѱ۷ιǾȸ)
hyein@krpia.or.kr / 02-501-2923





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