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The ICH Steering Committee will meet from June 6–11, 2015 to discuss a variety of harmonization topics.
The International Conference on Harmonization’s (ICH’s) ICH Week will occur from June 6–11, 2015 in Fukuoka, Japan, where a variety of harmonization topics affecting the pharmaceutical industry will be discussed. The week’s agenda includes a session on global cooperation, a meeting of the ICH Medical Dictionary for Regulatory Activities (MedDRA) Management Board, the International Pharmaceutical Regulators Forum, as well as meetings involving ICH technical working groups.
Included in the discussions will be status updates on the implementation of ICH guidelines. Among the guidelines to be addressed are:
· S5(R3) Revision of Detection of Toxicity to Reproduction for Medicinal Products and Toxicity to Male Fertility
· S11 ICH Guideline on Nonclinical Safety Testing in support of Development of Paediatric Medicines
· Q12 Guideline on Life Cycle Management
· E11(R1) Addendum to Paediatric Drug Development
· E18 ICH Guideline on Genomic Sampling Methodologies for Future Use
· M2 Electronic Standards for the Transfer of Regulatory Information
· M8 The Electronic Common Technical Document: eCTD.
The week will also include a membership update and the discussion and organization of ICH training activities. The full agenda can be found on ICH’s website.