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Joint Audit Programme for EEA GMP Inspectorates 7 Westferry Circus Canary Wharf London E14 4HB UK Tel 4420 74 18 84 00 Fax 4420 74 18 85 95 Email gmpemeaeuropaeu httpwwwemea. 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 . The inspection of GVK that led to the CHMP’s recommendation was carried out by the French medicines agency (ANSM). The inspectionrevealed data manipulations of electrocardiograms (ECGs) durin 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 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 The majority of international regulatory authorities are obliged by law to have systems in place to verify As an initial effort to improve international sharing of information and to facilitate more 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 Joint Audit Programme for EEA GMP Inspectorates 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 85 95 E-mail: gmp@emea.europa.eu http://www.emea. Joint Audit Programme for EEA GMP Inspectorates 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 85 95 E-mail: gmp@emea.europa.eu http://www.emea. (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 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