PDF-European Medicines Agency Westferry Circus Canary Wha

Author : pasty-toler | Published Date : 2015-05-19

4420 74 18 84 00 Fax 4420 74 18 85 45 Email mailemeaeuropaeu httpwwwemeaeuropaeu EMEA 2007 Reproduction andor distribution of this document is authorised for non

Presentation Embed Code

Download Presentation

Download Presentation The PPT/PDF document "European Medicines Agency Westferry Cir..." is the property of its rightful owner. Permission is granted to download and print the materials on this website for personal, non-commercial use only, and to display it on your personal computer provided you do not modify the materials and that you retain all copyright notices contained in the materials. By downloading content from our website, you accept the terms of this agreement.

European Medicines Agency Westferry Circus Canary Wha: Transcript

4420 74 18 84 00 Fax 4420 74 18 85 45 Email mailemeaeuropaeu httpwwwemeaeuropaeu EMEA 2007 Reproduction andor distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged London 16 January 2007 Doc R. 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 European Medicines Agency 2014 Reproduction is authorised provided the source is acknowledged 21 March 2014 EMA CHMPCVMPQWP4410712011 Rev2 Committee for Medicinal Products for Human Use CHMP Committee for Medicinal P 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 2(5) 3. Submission of request The request for a recommendation for classification from the MAH for a centrally authorised product shall be submitted to the EMEA electronically to a dedicated mail 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 (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 ICH Topic Q 3 B (R2) Impurities in New Drug Products TRANSMISSION TO INTERESTED PARTIES November 1999 RELEASE FO DEADLINE FOR COMMENTS May 2000 APPROVAL BY CPMP February 2003 DATE FOR COMING INT 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 Topic E 9 Statistical Principles for Clinical Trials Step 5 NOTE FOR GUIDANCE ON STATISTICAL PRINCIPLES FOR CLINICAL TRIALS (CPMP/ICH/363/96) TRANSMISSION TO CPMP February 1997 RELEASE FOR CONS ICH Topic E 7 Studies in Support of Special Populations: Geriatrics Step 5NOTE FOR GUIDANCE ON STUDIES IN SUPPORT OF SPECIAL POPULATIONS: GERIATRICS (CPMP/ICH/379/95) APPROVAL BY CPMP September 1

Download Document

Here is the link to download the presentation.
"European Medicines Agency Westferry Circus Canary Wha"The content belongs to its owner. You may download and print it for personal use, without modification, and keep all copyright notices. By downloading, you agree to these terms.