PA2 ICH

ICH

• International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
• International Convention for Healthcare
• International Cooperation for Health and Safety
• International Commission on Healthcare

Founding Members of ICH, EXCEPT

• Europe
• United States
• Japan
• Australia

FDA, United States

• ICH Founding Regulatory Member
• ICH Founding Industry Member

Q in QSEM stands for

S in QSEM stands for

E in QSEM stands for

To uncover potential risk like carcinogenicity, genotoxicity and reprotoxicity

• Quality
• Safety
• Efficacy
• Miscellaneous
• Multi-Disciplinary

Topics which do not fit uniquely into one of the Quality, Safety and Efficacy categories

• Quality
• Safety
• Efficacy
• Miscellaneous
• Multi-Disciplinary

Concerned with the design, conduct, safety and reporting of clinical trials

• Quality
• Safety
• Efficacy
• Miscellaneous
• Multi-Disciplinary

Carcinogenicity Testing

• Quality
• Safety
• Efficacy
• Miscellaneous
• Multi-Disciplinary