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

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. 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 74 18 85 45 Email mailemeaeuropaeu http wwwem eaeuropaeu EMEA 2007 Reproduction andor distribution of this document is authoris ed for non commercial purposes only provided the EMEA is acknowledged London 19 July 2007 Doc R 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 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 (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 European Medicines Agency www.ema.europa.eu Heads of Medicines Agencies www.hma.eu The European Medicines Agency is an agency of the European Union (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 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 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 Page 2 of 7
EMEA 2005 TABLE OF CONTENTS 1. INTRODUCTION.....................................................................................................................3 1.1 R 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 of Pharmacy . Practice. Dr. Haider Raheem. Tracing the origins of pharmacy. Sumerians. • The development of cuneiform writing on clay tablets during the third millennium BC included lists of drugs of animal, vegetable and mineral origin that were used in the management of diseases, and prescriptions with details of the ingredients used in their compounding.