The international Council of Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) provides a unique opportunity for the regulators and the pharmaceutical industry to come together and discuss harmonize the technical requirements needed for developing safe and effective medicines in the most resource efficient manner. This presentation provides the ICH history since its foundation in 1990, the ICH process, the ICH members and observers, and the evolution of the ICH-M10 guideline on Bioanalytical Method Validation and Study Sample Analysis. In addition, it will discuss the expectations on M10 implementation in different regions.
Learning Objectives:
Understand the ICH Process
Learn about ICH members and observers
Understand the evolution of bioanalytical method validation guidelines in different regions leading to ICH-M10
Understand the expectation for implementation of ICH-M10 in different regions
