Regulatory and Industry experts will reflect on progress on global regulatory harmonization of requirements for the development of medicines since the founding of ICH and it’s expanded global footprint following the reforms in 2015.
Learning Objectives
Assess progress in global harmonization of regulatory requirements for the development of medicines since ICH reforms in 2015; Evaluate impact of specific ICH guidelines in global drug development such as E6 Good Clinical Practice, E17 Multi-Regional Clinical Trials and Q9 Quality Risk Management; Identify opportunities for greater regulatory harmonization to advance global drug development.