Showing XXX results across 3 categories.
The ICH S9 Questions and Answers (Q&As) on the Nonclinical Evaluation for Anticancer Pharmaceuticals, reached Step 4 of the ICH Process in April 2018.
The ICH Q11 Questions and Answers (Q&As) on the Development and Manufacture of Drug Substances are intended to provide additional clarification on the selection and justification of starting materials.
The ICH M9 Biopharmaceutics Classification System-based Biowaivers reached Step 2b of the ICH Process in June 2018 and now enters the consultation period.
The International Council for Harmonisation (ICH) met in Kobe, Japan on 2 – 7 June 2018.
The MedDRA Management Committee noted significant achievements in supporting the global expansion of MedDRA use.
The MedDRA Management Committee noted significant achievements in supporting the global expansion of MedDRA use, in accordance with the five-year strategic plan.
The International Council for Harmonisation (ICH) met in Kobe, Japan on 2 – 7 June 2018. In one of the remaining steps of implementing the 2015 reforms of ICH, the Assembly elected additional members to the Association’s Management Committee.
The ICH Q3D(R1) Revision of the ICH Q3D Guideline for Elemental Impurities reached Step 2b of the ICH Process in May 2018 and now enters the consultation period.