PDF-INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FO

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. O Box 195 1211 Geneva 20 Switzerland Telephone 41 22 338 32 06 Telefax 41 22 338 32 30 adminichorg httpwwwichorg Final Concept Paper Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management dated 28 July 2014 Endors 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 Joint World Bank-LIS . Workshop . on database creation and survey harmonization.  . Thursday, June 6, 2013. LIS: an overview. LIS: Cross-National Data Center . • parent . organization . • located in Luxembourg. 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 Q4B Annex 8(R1) Document History Date Q4B Annex 8 Approval by the Steering Committee under and release for public consultation. 13 November 2008 Q4B Annex 8 Approval by the Steering Committee unde 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 IN THE CUSTOMS UNION AND . THE COMMON ECONOMIC SPACE. Valery N. . Koreshkov. Minister for . Technical Regulation . Member of the . Board . of the Eurasian Economic Commission . еес. . EURASIAN. . 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. ICH Bracketing and matrixinp: designs for stabil& testing of drug substances and drug prod-u& cx *$-T* Step 2 November 2000 This draft guidance, when fmlized, will represent the Food and Drug Admin (PAOC). . . Ronald Cross Eugene Short Jr.. Quality Assurance Representative Quality Assurance Subject Matter Expert. . EXTBE Team Mission Assistance Group . . Defense Contracts Management Agency. CHEP2015. April 13. th. -17. th. , 2015. Okinawa Institute of Science and Technology Graduate University. Onna. , Okinawa, Japan. 21st International Conference on Computing in High Energy and Nuclear Physics, . Giuseppe . Tagliente. Istituto. . Nazionale. . Fisica. . Nucleare. , . Sezione. di Bari, Italy. Recent results at the . n_TOF. . facilty. (. CERN. ). on behalf of . n_TOF. . Collaboration. n_TOF.