Training Presentation to ICH Q11 Draft Q&A
The ICH (International Council for Harmonisation) has developed a training presentation on the ICH Q11 Q&A document Selection & Justification of Starting Materials. Therein the Expert Working Group gives answers to the following questions:
- Why is the Q&A document needed now?
- What is the perceived problem?
- What are the implications of the document?
- What is the scope relative to the parent guideline?
- What general principles have to be considered on Section 5.1.1 Selection of Starting Materials for Synthetic Drug Substances and Section 5.2.1 Justification of SM selection for synthetic drug substances?
- What are the main issues that need to be resolved?
- What are the potential benefits from further guidance?
- What additional guidance is provided?
- What is the current state of the document?
Click here for direct access to the PowerPoint Presentation.