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ealtEMA Regulatory Science to 2025Strategic rex0066006CectionContentsForeword by Prof Guido Rasi EMA Executive Director1Vision 151 Human medicines2Vision 151 Veterinary medicines41 Introduction 151 th. 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 . 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 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 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. EMA146s third public meeting 26 March 2021PCWP / HCPWP meeting 2 March 2021Nathalie BerePublic and Stakeholders Engagement DepartmentClassified as public by the European Medicines Agency ENGAGING THE 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