Showing XXX results across 3 categories.
The Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice (GCP) reached Step 4 of the ICH Process in November 2016.
The ICH Q11 Questions and Answers (Q&As) on the Development and Manufacture of Drug Substances, regarding the selection and justification of starting materials, reached Step 2b of the ICH Process in November 2016 and now enters the consultation period.
The ICH MedDRA Management Board met in Osaka, Japan on November 5-6, 2016 and announces reductions in Subscription Rates for MSSO Subscribers.
Osaka, Japan 2016 – The MedDRA Management Board met in Osaka, Japan on 5-6 November 2016.
The International Council for Harmonisation (ICH) met in Osaka, Japan on 5-10 November 2016.
First new regulatory Members of ICH, key global good clinical practice guideline revisions agreed.
The ICH E11(R1) draft Addendum Guideline on Clinical Investigation of Medicinal Products in the Pediatric Population reached Step 2b of the ICH Process in October 2016 and now enters the consultation period (Step 3).
In October 2016, the ICH endorsed a new topic for the development of a new multidisciplinary guideline to address Biopharmaceutics Classification System (BCS)-based biowaivers.