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ICH Bracketing and matrixinp designs for stabil testing of drug substances and drug produ cx T Step 2 November 2000 This draft guidance when fmlized will represent the Food and Drug Admin. ARMONISED RIPARTITE UIDELINE IMPURITIES IN NEW DRUG PRODUCTS Q3B(R2) Current Step 4 version dated 2 June 2006 This Guideline has been developed by tation by the regulatory parties, in accordance w ARMONISED RIPARTITE UIDELINE UALITY ANAGEMENT Q9 Current Step 4 version dated 9 November 2005 This Guideline has been developed by tation by the regulatory parties, in accordance with the al draft Q11 History Q11 Approval by the Steering Committee under and release for public consultation. 19 May 2011 History Q11 Approval by the Steering Committee under and recommendation for adoption to the i REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH H ARMONISED T RIPARTITE G UIDELINE P HOTOSAFETY E VALUATION OF P HARMACEUTICALS S10 Current Step 4 version dated 13 November 2 Q3C(R5) Document History First Codification History Date New Codification Parent Guideline: Impurities: Guideline for Residual Solvents Q3C Approval by the Steering Committee under and release for p ICH HARMONISED TRIPARTITE GUIDELINE DOSE-RESPONSE INFORMATION TO SUPPORT DRUG REGISTRATION E4 Current Step 4 version dated 10 March 1994 This Guideline has been developed by the ulatory parties, REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH H ARMONISED T RIPARTITE G UIDELINE E VALUATION A ND R ECOMMENDATION O F P HARMACOPOEIAL T EXTS F OR U SE I N T HE ICH R E RIPARTITE HOICE OF ONTROL ROUP AND ELATED SSUES IN LINICAL RIALS E10 Step 4 dated 20 July 2000 This Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to Palvi. Shah and Becki Aquilina. 1. Overview. ONS Quality Goals and Harmonisation. The Harmonisation Vision and Strategy. Harmonisation Planning and Process. Benefits of Harmonisation. Issues and Considerations. Q_2014. Vlasta Zucha. Richard Heuberger. Directorate. . Social. . Statistics. Vienna. 3 . June . 2014. Motivations. . for. . harmonisation. Microcensus Housing Survey. , Household Budget Survey, . (PAOC). . . Ronald Cross Eugene Short Jr.. Quality Assurance Representative Quality Assurance Subject Matter Expert. . EXTBE Team Mission Assistance Group . . Defense Contracts Management Agency. Dr. Michael . J.D. . Sutton. msutton@westminstercollege.edu. michaeljdsutton@gmail.com. Copyright . ©. . 2013 . Michael JD Sutton. No part of this presentation may be reproduced without the permission of the author. . Alexander Kühn. CEPT. Legal and Procedural Implementation. International Specifications & Agreements. Technical Regulatory. Aspects. Economic and . Competion. Aspects. Baseline for spectrum regulation: Harmonisation. WG NaN Activities in Harmonisation in Numbering. 5. th. WG NaN meeting. Stockholm, 21-22 November 2012. Jan Vannieuwenhuyse, Jukka Rakkolainen. NaN(2012)031rev1. See document NaN(2012)030rev1. 112. 116.