21 August 2014

During summer 2014, the ICH Steering Committee approved the establishment of four new ICH Efficacy Expert Working Groups:

  • E6(R2) EWG to work on the development of an Addendum to the current E6(R1) Guideline on Good Clinical Practices
  • E11(R1) EWG to work on the development of an Addendum to the current ICH E11 Guideline on Clinical Investigation of Medicinal Products in the Pediatric Population
  • E17 EWG to develop a new Guideline on General Principle on Planning/Designing Multi-Regional Clinical Trials (MRCTs)
  • E18 EWG to develop a new Guideline on Genomic Sampling Methodologies for Future Use

 

More information on each of these topics is available in the Concept Papers and Business Plans available for each topic on the Efficacy Guideline page.