The S6(R1) EWG reached Step 4 on the Addendum to the S6 Guideline “Revision of Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals.”
Milrinone End of procedure: 09/04/2011 Date of publication: 06/07/2011
The ICH Q11 Guideline on Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) reached Step 2 of the ICH Process in May 2011 and now enters the consultation period (Step 3).
The International Conference on Harmonisation (ICH) Steering Committee (SC) and its working groups met in Cincinnati, Ohio from June 11-16, 2011.
Cincinnati, 12 June 2011 – The MedDRA Management Board met in Cincinnati, Ohio, USA on 11 - 12 June 2011.
The final meeting report of the last Global Cooperation Group (GCG) meeting that was held in Fukuoka, Japan on November 9, 2010 is now available on the ICH website under the GCG Reports page.
Paediatric Regulation: Article 45 Template for AR for paediatric studies submitted in accordance with Article 45 of Regulation (EC) No 1901/2006 (April 2025) [Track version]
Recommendations on contacts with Representative Organisations (March 2017) [Track version]
To highlight the 20th Anniversary of ICH, DIA has published a series of articles on ICH in the April 2011 edition of its Global Forum Magazine.
A public meeting entitled “Preparation for ICH Steering Committee and Expert Working Group Meetings in Cincinnati, Ohio” will be held on 19 May 2011, in Rockville, Maryland.