PDF-INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL

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. 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 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, 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 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 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and matrixinp: designs for stabil& testing of drug substances and drug prod-u& cx *$-T* Step 2 November 2000 This draft guidance, when fmlized, will represent the Food and Drug Admin POST. -HARMONISATION . – TAX EXCEPTIONALISM OR JURISPRUDENTIAL CONSISTENCY?. RITA DE LA FERIA. (CENTRE FOR BUSINESS TAXATION, OXFORD UNIVERSITY). DIMITRIOS DOUKAS. (SCHOOL OF LAW, QUEEN’S UNIVERSITY BELFAST). 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 Standards . Workshop on ASEAN Common Food Control Requirements. 14-15 July . 2014, . Jakarta, Indonesia. 7/8/2014. 1. Standards in the SPS . Agreement. Article . 3: Harmonization. To . harmonize sanitary and phytosanitary measures on as wide a basis as possible, Members . 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.