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[ICH 2019] Safety Program(9/5) з
û 2019.08.07~2019.08.28 2019.09.05~2019.09.05
׷ư, ޶Ȧ ð 10:00 - 18:00
÷ ICH 2019_Program_KoBIA_0826.pdf

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9 5, ׷ư ޶Ȧ(3F)

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9:30 - 10:00 (30') 
Registration /  
ICH S3 A/B : Toxicokinetics & Pharmacokinetics
10:00 - 11:10 (70') 
Understanding and Applying Toxicokinetics in Drug Development
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Jin A Hwang (Professor, Konyang University)
11:10 - 11:30 (20')  Coffee Break
11:30 - 12:40 (70') 
An Overview of ICH S3 Guideline Questions and Answers
ICH S3A QnA ؼ PMDA 㰡ɻ
Jihei Nishimura (Principal Assessor, PMDA)
12:40 - 14:00 (80')  Lunch 
ICH Pharmacology Studies Guidelines: S7 A/B

14:00 - 15:10 (70') 
Introduction of safety pharmacology and basic mechanism of TdP and QT interval prolongation
ฮ ؿ QT 忡 ߻ ̷
Jeong Wook Seo (Executive Director, KIT)
15:10 - 15:30 (20')  Coffee Break
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 ӻ/ӻ 򰡻  
Colette Strnad (Senior Scientific Advisor, Health Canada)
17:50 - 18:00 (10')  Closing
2019 ICH ̵
  • Ͻ: 9 4() 09:30 - 18:00
  • : ׷ư Ȧ(3F)

  • Q6A/B: Specification
    Q1A/D: Stability Test
    Q5A/B/D: Biopharmaceutical products

  • Health Canada, Z̿ǽ, Ʈ,
    ȭ and more! 
  • 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() 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 *
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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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