PDF-European Medicines Agency7 Westferry Circus, Canary Wharf, London, E14

Author : debby-jeon | Published Date : 2016-07-05

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

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European Medicines Agency7 Westferry Circus, Canary Wharf, London, E14: Transcript

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. 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 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 ICH Considerations General Principles to Address the Risk of Inadvertent Germline Integration of Gene Therapy Vectors TRANSMISSION TO CHMP November 2006 RELEASED FOR INFORMATION November 2006 (CHMP) REFLECTION PAPER DRAFT AGREED BY BIOSIMILAR MEDICINAL PRODUCTS WORKING PARTY (BMWP) October 2007 KEYWORDS Interferon alfa, recombinant, similar biological medicinal products, comparability, ICH Topic Q 5 A (R1) Quality of Biotechnological Products: Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin Step 5 NOTE FOR GUIDANCE ON QUALITY O (CHMP) REFLECTION PAPER ON METHODOLOGICAL ISSUES IN CONFIRMATORY CLINICAL TRIALS PLANNED WITH AN ADAPTIVE DESIGN DRAFT AGREED BY THE EFFICACY WORKING PARTY 11 January 2006 ADOPTION BY CHMP FOR REL 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 (CHMP) GUIDELINE ON STRATEGIES TO IDENTIFY AND MITIGATE RISKS FOR FIRST-IN- HUMAN CLINICAL TRIALS WITH INVESTIGATIONAL MEDICINAL PRODUCTS DRAFT AGREED BY CHMP EXPERT GROUP 6 March 2007 ADOPTION BY ● 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 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 Comparability of Biotechnological/Biological Products Step 5 NOTE FOR GUIDANCE ON BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS SUBJECT TO CHANGES IN THEIR MANUFACTURING PROCESS CPMP/ICH/5721/03TRANSMISSION 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 ICH Considerations General Principles to Address the Risk of Inadvertent Germline Integration of Gene Therapy Vectors TRANSMISSION TO CHMP November 2006 RELEASED FOR INFORMATION November 2006

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