PDF-INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FO

ICH HARMONISED TRIPARTITE GUIDELINE STUDIES IN SUPPORT OF SPECIAL POPULATIONS GERIATRICS E7 Current Step 4 version dated 24 June 1993 This Guideline has been developed by the ulatory parties. REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE - 1 - Final Concept P aper M7 : Assessment and C ont rol of DNA R eactive ( M utagenic) I mpurities in P harmaceuticals to Limit P 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 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 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 RIPARTITE HE NTERVAL ROLONGATION AND ROARRHYTHMIC E14 Step 4 dated 12 May 2005 This Guideline has been developed by tation by the regulatory parties, in accordance with the al draft is recommended Q_2014. Vlasta Zucha. Richard Heuberger. Directorate. . Social. . Statistics. Vienna. 3 . June . 2014. Motivations. . for. . harmonisation. Microcensus Housing Survey. , Household Budget Survey, . Alexander Kühn. CEPT. Legal and Procedural Implementation. International Specifications & Agreements. Technical Regulatory. Aspects. Economic and . Competion. Aspects. Baseline for spectrum regulation: Harmonisation. DR DORCAS PETA. 1 JUNE 2012. ACKNOWLEDGEMENT. This presentation is a summary of presentations delivered at ARC by the various speakers. It is intended to provide feedback to SAPRAA members who were unable to attend the conference. . Chairman of the Malta Medicines Authority. Medicines Authority. 203,Level 3,. Rue D’Argens,. Gzira,GZR 136. 8. Tel: ( 356) 2343 9000. Fax: ( 356) 2343 9161. Email: . anthony.serracino-inglott. @gov.mt. 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.