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&As |
The 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) |
 |
 |
 |