PDF-European Medicines Agency Evaluation of Medicines for Human Use7 Westf

COMMITTEE ABBREVIATION GUIDELINE ON VIRUS SAFETY EVALUATION OF BIOTECHNOLOGICAL INVESTIGATIONAL MEDICINAL PRODUCTS DRAFT AGREED BY BWP May 2006 ADOPTION BY CHMPFOR RELEASE FOR CONSULTATION 28 Ju. emaeuropaeucontact European Medicines Agency 2014 Reproduction is authorised provided the source is acknowledged 21 July 2011 EMEACHMPEWP1922172009 Rev1 Corr Committee for Medicinal Products for Human Use CHMP Guideline on bioanalytical method vali 4420 74 18 84 00 Fax 4420 74 18 84 09 Email mailemeaeuropaeu httpwwwemeaeuropaeu EMEA 2008 Reproduction andor distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged London 11 December 2007 CPMP 4420 74 18 84 00 Fax 4420 75 23 70 51 Email mailemeaeuropaeu httpwwwemeaeuropaeu EMEA 2007 Reproduction andor distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged London 26 October 2006 Doc R (CHMP) GUIDELINE ONTHE CHOICE OF THE NON-INFERIORITY MARGIN DRAFT AGREED BY THE EFFICACY WORKING PARTY ADOPTION BY COMMITTEE FOR RELEASE FOR CONSULTATION February 2004 AGREED BY WORKING PARTY June (CHMP) SEALANT/HAEMOSTATIC PRODUCTS (CPMP/BPWG/153/00) DISCUSSION IN THE BLOOD PRODUCTS WORKING GROUP DISCUSSION IN THE PHARMACOVIGILANCE WORKING PARTY April 2001 TRANSMISSION TO THE CPMP Decembe EMEA/CHMP/BMWP/31329/2005 Page 2/6
EMEA 2006 TABLE OF CONTENTS EXECUTIVE SUMMARY...................................................................................................................3 GUIDELINE ON THE LIMITS OF GENOTOXIC IMPURITIES DISCUSSION IN THE SAFETY WORKING PARTY DEADLINE FOR COMMENTS DISCUSSION IN THE SAFETY WORKING PARTY AND QUALITY WORKING PARTY June 2003 - February COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) COMMITTEE FOR MEDICINAL PRODUCTS FOR VETERINARY USE (CVMP) GUIDELINE ON DECLARATION OF HERBAL SUBSTANCES AND HERBAL PREPARATIONS IN HERBAL MEDIC Harmonization and . African Medicines Agency. Margareth Ndomondo-Sigonda. NEPAD . Planning and Coordinating Agency. Midrand, Johannesburg. South Africa. OUTLINE. Introduction to NEPAD. Background and Overview of the African . ealtEMA Regulatory Science to 2025Strategic rex0066006CectionContentsForeword by Prof Guido Rasi EMA Executive Director1Vision 151 Human medicines2Vision 151 Veterinary medicines41 Introduction 151 th Answers to Knowledge Check in the post-event surveySME and academia Clinical Trials Information System CTIS two-part training webinar day 2Classified as public by the European Medicines Agency Europe The . HDA (formerly BAPW) . Who we are. Good Distribution Practice . HDA is a UK-wide representative trade association whose mission is to advance the interests and values of those member companies who provide . COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) GUIDELINE ON THE EVALUATION OF THE PHARMACOKINETICS OF MEDICINAL PRODUCTS IN PATIENTS WITH IMPAIRED HEPATIC DISCUSSION IN THE EFFICACY WORKIN (CHMP) GUIDELINE ON CLINICAL INVESTIGATION OF MEDICINAL PRODUCTS FOR HORMONE REPLACEMENT THERAPY OF OESTROGEN DEFICIENCY SYMPTOMS IN POSTMENOPAUSAL WOMEN DRAFT AGREED BY THE EFFICACY WORKING PARTY