Training on ICH Guideline
2020년 ICH 가이드라인 교육
일정
2020년 11월 3일(화) - 6일(금) | 온라인 중계
주최
주최
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세부 프로그램
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온라인 교육
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질의응답 공개
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E-수요조사
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문의
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ICH Programs Speakers Video Materials KOR ENG Files 2020 ICH ICH Cooperation Activity and Implementation Status of ICH Guidelines in Korea Youngju Choi
(NIFDS, MFDS)
2019 ICH ICH Guidelines and New Drug Development Hoonjoo Kim
(DGMIF)
2018 ICH Development Status and Plan of ICH Joung-Weon Oh
(NIFDS, MFDS)
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ICH Programs Speakers Video Materials KOR ENG Files 2020 S6+M3 A Comparison of ICH S6 and ICH M3 Jian Wang
(Health Canada)S6 Considerations for Nonclinical Studies of Biopharmaceuticals Sang Yeon Oh
(NIFDS, MFDS)S5(R3) S5(R3): Detection of Reproductive and Developmental Toxicity for Human Pharmaceuticals Wook-Joon Yu
(Korea Institute of Toxicology)S11 Nonclinical Paediatric Safety Joo Young Cha
(JW Holdings)2019 S7A/B Introduction of safety pharmacology and basic mechanism of TdP and QT interval prolongation Jeong Wook Seo
(Korea Institute of Toxicology)S3A
QnAAn Overview of ICH S3A Guideline Q&As Jihei Nishimura
(PMDA)
S3A/B Understanding and Applying Toxicokinetics in Drug Development Jin Ah Hwang
(Konyang University)S7B(+E14) A Regulatory Perspective on Implementation of the ICH S7B and E14 Guidelines on the Non-Clinical and Clinical Evaluation of QTc Prolongation Potential Colette Strnad
(Health Canada)2018 S9 ICH S9: Nonclinical evaluation for acticancer pharmaceuticals Donghwan Kim
(Konyang University)S9 Q&A An Overview of ICH S9 Guideline Q&As Keiji Hirabayashi
(PMDA)S2(R1) Genetic Toxicity Testing of Pharmaceuticals Seong-Hoon Park
(Korea Institute of Toxicology)S6 Preclinical Safety Evaluation of Biotechnology-derived Pharmaceuticals Woo S. Koh
(DGMIF)S6 Q&A An Overview of ICH S6 Q&A Mineo Matsumoto
(PMDA) -
ICH Programs Speakers Video Materials KOR ENG Files 2020 Q12 Pharmaceutical Product Lifecycle Management Jean-Louis ROBERT
(EC_EU ICH Q12 topic lead)Q12 Practical Implementation of ICH Q12 Frank Montgomery
(AstraZeneca)Q8/9/10 Strategic interpretation of ICH Q8, 9, and 10 approaches Tae Kyu Kim
(BnP Care)Q8/9/10 Interpretation and implementation of ICH Q-trio from the industry perspective Hyun Cheol Kim
(Hanmi Pharm.)Q8/9/10
Q&AsThe road to drug development and license by QbD Cook Hee Kim
(K-Bio NDDC)2019 Q6B ICH Guidelines on Specifications for Biotechnological/Biological Producats (Q6B): Health Canada’s experience Hugo Hamel
(Health Canada)Q1A(R2), Q1D Experience in Implementing ICH Stability Guidelines Q1A(R2) and Q1D with Case Studies Chi-wan Chen
(Pfizer)Q5A Health Canada’s experience with the application of ICH Guidelines on Viral Clearance for Biotechnological/Biological Products Christopher Storbeck
(Health Canada)Q5B/D Quality of Biotechnological Product: Analysis of Expression Construct (Q5B) and Derivation/Characterization of Cell Substrates (Q5D) Myongjin Kim
(Celltrion)2018 Q5C Quality of Biotechnological Products SeonMi Shin
(Celltrion)Q11 Overview and Application of ICH Q11 for API Unit Operation Samsik Kim
(Anygen)Q11 Q&A Q11 Guidelines Q&As Kazuhiro Okochi
(Takeda)Q1A/B/E ICH Stability Q1A,B,E Chang-ju Kim
(Search & Tran) -
ICH Programs Speakers Video Materials KOR ENG Files 2020 M1 MedDRA Applications: Coding and Data Analysis Yunhui DO
(MedDRA MSSO)M4 The Common Technical Document Jeong Uk LEE
(ICURE)
M9 Biopharmaceutics Classification System-Based Biowaivers ICH M9 James Mann
Xavier Pepin
(AstraZeneca)M9 Revision on BCS-Based Biowaivers as establishment of M9 Kyungshin Lee
(NIFDS, MFDS)2019 M3(R2) Nonclinical Safety Studies for IND and NDA Donghwan Kim
(Konyang University)M3(R2)
Q&AM3(R2) Q&A with case studies Richard Haworth
(GSK)M7 General Principles of ICH M7 Jumi Kim
(Dong-A ST)M7 ICH M7 Addendum: Derivation of compound-specific acceptable intakes/Permissible Daily Exposure for impurities in pharmaceuticals Patricia Parris
(AstraZeneca)2018 M1 Introductory Guide for MedDRA Jihye Ha
(NIFDS, MFDS)M1 MedDRA Coding Basic Jung Min Lee
(LSK)M4 CTD Jeong Uk LEE
(Sungkyunkwan University)M4 eCTD: Adding the ‘e’ to the CTD Katie Lewis
(Amgen)M4 eCTD Around the World Jared Lantzy
(Lorenz Life Sciences Group) -
ICH Programs Speakers Video Materials KOR ENG Files 2020 E2B(R3) E2B(R3) to improve the quality of Individual Case Safety Reports (ICSRs) JEAN-CHRISTOPHE DELUMEAU
(Bayer Pharma AG)E2C How to prepare PBRER and DSUR - ICH E2C and ICH E2F Shuguang (Dawn) REN
(Bayer AG)E6(R2) More systematic prioritized risk-based approach: successful implementation in Clinical Development Taekrho Kim
(F. Hoffmann-La Roche)E16 An Introduction to ICH E16 and Biomarker Qualification Gideon Blumenthal (MSD) 2019 E2B(R3) ICH E2B(R3) Guideline of China Stella Xu
(Dmed)E2B(R3) Post-marketing Drug Safety Surveillance: Pharmacovigilance in MFDS Yubin Lee
(NIFDS, MFDS)E2B(R3) Implementation of E2B(R3) Yukie Yamaguchi E2A ICH E2A ? Clinical Safety Data Management: Definitions and Standards for Expedited Reporting Gerald Dal Pan
(FDA)E2A Preparing for Regulatory Inspection Readiness Through Internal Audits Moin Don
(PVCON)E9 A summary of the key messages in ICH E9, an introduction to Estimands and the Addendum to ICH E9 David Wright
(AstraZeneca)2018 E17 How should we prepare for MRCT? SeungHwan Lee
(Seoul National University)E17 MRCT Implementation in China Michelle Wang
(MSD)E6(R2) Risk Based Monitoring in E6(R2) and Regulatory Guidance Gyu Ri Bae
(MSD)E6(R2) E6 Risk-Based Quality Management in Clinical Trials Kwansook Lee
(Novartis)E6(R2) Cases on Clinical Audit and Inspection Eun-Hee Kim
(CQA)
ICH Guideline By Year
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2020
2019Multidisciplinary Efficacy Safety Quality Nov 3(Tue) Nov 4(Wed) Nov 5(Thu) Nov 6(Fri) M1 E6 S5(R3) Q12 M4 E2B, E2C S11 Q8,9,10 M9 E16 S6+M3 Q8,9,10 Q&As
2018Quality & Multidisciplinary Efficacy & Safety Sept 4(Wed) Sept 5(Thu) Q6A/B M3(R2) E2A/B S3(Q&A)/B Q1A/D M7(R1) E9 S7A/B Q5A, Q5B/D Safety Quality Multidisciplinary & Efficacy Nov 27(Tue) Nov 28(Wed) Nov 29(Thu) Nov 30(Fri) S9(Q&A) Q1A/B/E, Q5C M4 E6 S2 Q11(Q&A) E17 M1 S6(Q&A) Q3A/B, Q3D -
ICH Programs Speakers Video Materials KOR ENG Files ICH ICH ICH Cooperation Activity and Implementation Status of ICH Guidelines in Korea Youngju Choi
(NIFDS, MFDS)Safety (안전성) S6+M3 A Comparison of ICH S6 and ICH M3 Jian Wang
(Health Canada)S6 Considerations for Nonclinical Studies of Biopharmaceuticals Sang Yeon Oh
(NIFDS, MFDS)S5(R3) S5(R3): Detection of Reproductive and Developmental Toxicity for Human Pharmaceuticals Wook-Joon Yu
(Korea Institute of Toxicology)S11 Nonclinical Paediatric Safety Joo Young Cha
(JW Holdings)Quality (품질) Q12 Pharmaceutical Product Lifecycle Management Jean-Louis ROBERT
(EC_EU ICH Q12 topic lead)Q12 Practical Implementation of ICH Q12 Frank Montgomery
(AstraZeneca)Q8/9/10 Strategic interpretation of ICH Q8, 9, and 10 approaches Tae Kyu Kim
(BnP Care)Q8/9/10 Interpretation and implementation of ICH Q-trio from the industry perspective Hyun Cheol Kim
(Hanmi Pharm.)Q8/9/10
Q&AsThe road to drug development and license by QbD Cook Hee Kim
(K-Bio NDDC)Multidisciplinary (복합) M1 MedDRA Applications: Coding and Data Analysis Yunhui DO
(MedDRA MSSO)M4 The Common Technical Document Jeong Uk LEE
(ICURE)M9 Biopharmaceutics Classification System-Based Biowaivers ICH M9 James Mann
Xavier Pepin
(AstraZeneca)M9 Revision on BCS-Based Biowaivers as establishment of M9 Kyungshin Lee
(NIFDS, MFDS)Efficacy (유효성) E2B(R3) E2B(R3) to improve the quality of Individual Case Safety Reports (ICSRs) JEAN-CHRISTOPHE DELUMEAU
(Bayer Pharma AG)E2C How to prepare PBRER and DSUR - ICH E2C and ICH E2F Shuguang (Dawn) REN
(Bayer AG)E6(R2) More systematic prioritized risk-based approach: successful implementation in Clinical Development Taekrho Kim
(F. Hoffmann-La Roche)E16 An Introduction to ICH E16 and Biomarker Qualification Gideon Blumenthal (MSD) -
ICH Programs Speakers Video Materials KOR ENG Files ICH ICH ICH Guidelines and New Drug Development Hoonjoo Kim
(DGMIF)Safety (안전성) S7A/B Introduction of safety pharmacology and basic mechanism of TdP and QT interval prolongation Jeong Wook Seo
(Korea Institute of Toxicology)S3A
QnAAn Overview of ICH S3A Guideline Q&As Jihei Nishimura
(PMDA)S3A/B Understanding and Applying Toxicokinetics in Drug Development Jin Ah Hwang
(Konyang University)S7B(+E14) A Regulatory Perspective on Implementation of the ICH S7B and E14 Guidelines on the Non-Clinical and Clinical Evaluation of QTc Prolongation Potential Colette Strnad
(Health Canada)Quality (품질) Q6B ICH Guidelines on Specifications for Biotechnological/Biological Producats (Q6B): Health Canada’s experience Hugo Hamel
(Health Canada)Q1A(R2), Q1D Experience in Implementing ICH Stability Guidelines Q1A(R2) and Q1D with Case Studies Chi-wan Chen
(Pfizer)Q5A Health Canada’s experience with the application of ICH Guidelines on Viral Clearance for Biotechnological/Biological Products Christopher Storbeck
(Health Canada)Q5B/D Quality of Biotechnological Product: Analysis of Expression Construct (Q5B) and Derivation/Characterization of Cell Substrates (Q5D) Myongjin Kim
(Celltrion)Multidisciplinary (복합) M3(R2) Nonclinical Safety Studies for IND and NDA Donghwan Kim
(Konyang University)M3(R2)
Q&AM3(R2) Q&A with case studies Richard Haworth
(GSK)M7 General Principles of ICH M7 Jumi Kim
(Dong-A ST)M7 ICH M7 Addendum: Derivation of compound-specific acceptable intakes/Permissible Daily Exposure for impurities in pharmaceuticals Patricia Parris
(AstraZeneca)Efficacy (유효성) E2B(R3) ICH E2B(R3) Guideline of China Stella Xu
(Dmed)E2B(R3) Post-marketing Drug Safety Surveillance: Pharmacovigilance in MFDS Yubin Lee
(NIFDS, MFDS)E2B(R3) Implementation of E2B(R3) Yukie Yamaguchi E2A ICH E2A ? Clinical Safety Data Management: Definitions and Standards for Expedited Reporting Gerald Dal Pan
(FDA)E2A Preparing for Regulatory Inspection Readiness Through Internal Audits Moin Don
(PVCON)E9 A summary of the key messages in ICH E9, an introduction to Estimands and the Addendum to ICH E9 David Wright
(AstraZeneca) -
ICH Programs Speakers Video Materials KOR ENG Files ICH ICH Development Status and Plan of ICH Joung-Weon Oh
(NIFDS, MFDS)Safety (안전성) S9 ICH S9: Nonclinical evaluation for acticancer pharmaceuticals Donghwan Kim
(Konyang University)S9 Q&A An Overview of ICH S9 Guideline Q&As Keiji Hirabayashi
(PMDA)S2(R1) Genetic Toxicity Testing of Pharmaceuticals Seong-Hoon Park
(Korea Institute of Toxicology)S6 Preclinical Safety Evaluation of Biotechnology-derived Pharmaceuticals Woo S. Koh
(DGMIF)S6 Q&A An Overview of ICH S6 Q&A Mineo Matsumoto
(PMDA)Quality (품질) Q5C Quality of Biotechnological Products SeonMi Shin
(Celltrion)Q11 Overview and Application of ICH Q11 for API Unit Operation Samsik Kim
(Anygen)Q11 Q&A Q11 Guidelines Q&As Kazuhiro Okochi
(Takeda)Q1A/B/E ICH Stability Q1A,B,E Chang-ju Kim
(Search & Tran)Multidisciplinary (복합) M1 Introductory Guide for MedDRA Jihye Ha
(NIFDS, MFDS)M1 MedDRA Coding Basic Jung Min Lee
(LSK)M4 CTD Jeong Uk LEE
(Sungkyunkwan University)M4 eCTD: Adding the ‘e’ to the CTD Katie Lewis
(Amgen)M4 eCTD Around the World Jared Lantzy
(Lorenz Life Sciences Group)Efficacy (유효성) E17 How should we prepare for MRCT? SeungHwan Lee
(Seoul National University)E17 MRCT Implementation in China Michelle Wang
(MSD)E6(R2) Risk Based Monitoring in E6(R2) and Regulatory Guidance Gyu Ri Bae
(MSD)E6(R2) E6 Risk-Based Quality Management in Clinical Trials Kwansook Lee
(Novartis)E6(R2) Cases on Clinical Audit and Inspection Eun-Hee Kim
(CQA)
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