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 Agenc y 2013 Reproduction is authorised provided the source is acknowledged 03 June May 2013 EMEACHMPBMWP428322005 Rev 1 Committee for Medicinal Products for Human Use CHMP Guideline on similar bio europaeu Website wwwemaeuropaeu 19 March 2014 EMA4308922013 Press Office Press release European Medicines Agency launches adaptive licensing pilot project mproving timely access for patient to new medicines p ilot explore adaptive licensing approa c Canary Wharf London E14 4HB An agency of the European Union Telephone +44 (0)20 7418 8400 Facsimil e +44 (0)20 7418 8416 E - mail info@ema.europa.eu Wbsite www.ema.europa.eu 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 An agency of the European Union Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7418 8447 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 Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7523 7129 E - mail info@ema.europa.eu Website www.ema.europa.eu 1 , but only in adults, and not necessarily in the same indication (or the same disease). The general lack of information and appropriate pharmaceutical formulations to support the administration of 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 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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