Training on Guideline

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