PDF-7 Westferry Circus London E14 4HB United Kingdom +44 (0)20 7418 8400

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7 Westferry Circus London E14 4HB United Kingdom +44 (0)20 7418 8400: Transcript

. europaeu Website wwwemaeuropaeu European Medicines Agency 2013 Reproduction is authorised provided the source is acknowledged 22 May 2013 CHMP43704 Rev 1 Committee for Medicinal Products for Human Use CHMP Guideline on Similar Biological Medicinal Canary Wharf London E14 4HB An agency of the European Union Telephone +44 (0)20 7418 8400 Facsimil +44 (0)20 7418 8416 E - mail info@ema.europa.eu Website www.ema.europa.eu Canary Wharf London E14 4HB United Kingdom An agency of the European Union Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7523 7129 E - mail info@ema.europa.eu Website Canary Wharf London E14 4HB United Kingdom Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7523 7129 E - mail info@ema.europa.eu Website www.ema.europa.eu Canary Wharf London E14 4HB United Kingdom An agency of the European Union Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7418 8416 E - mail info@ema.europa.eu Website www.ema.europa.eu +44 (0)20 7418 8400 Facsimile +44 (0)20 7523 7040 E-mail info@ema.europa.eu Website Agreed by Biostatistic Working Party 15 May 2012 Agreed by COMP 10 May 2012 Adoption by PDCO 16 May 2012 Adoption ● Canary Wharf ● London E14 4HB ● United Kingdom An agency of the European Union Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7523 7129 E - mail info@ema.europa.eu Webs Political Competition United Kingdom United Kingdom intro How do groups in the UK compete for political power? Party System United Kingdom United Kingdom Party Systems Majoritarian system makes parties very important ICH Topic E 10 Choice of Control Group in Clinical Trials NOTE FOR GUIDANCE ON CHOICE OF CONTROL GROUP IN CLINICAL TRIALS TRANSMISSION TO CPMP June 1999 LTATION June 1999 DEADLINE FOR COMMENTS Decem ICH Topic E 1 Population Exposure The Extent of Population Exposure to Assess Clinical Safety Step 5NOTE FOR GUIDANCE ON POPULATION EXPOSURE THE EXTENT OF POPULATION EXPOSURE TO ASSESS CLINICAL SAFETY

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