Sheffield, United Kingdom
Genotoxic Impurities in
GTI strategies & new methodologies: analysis, in silico & regulations. Challenges & opportunities.
Pharmaceuticals Summit 2019
- 11 Apr 2019
- Berlin, DE
Day 1: Thursday, 11 April 2019
CASE STUDY: ICH M7 and potential mutagenic impurities; control strategy, analysis and regulatory response.
- Considerations in a risk assessment and technical position statement.
- Desired qualities for PMI analytical methodology.
- When is it applicable to use ICH M7 option 4?
- Current regulatory challenges
- Examples of regulatory communications/discussions