PDF-Westferry Circus Canary Wharf London E HB United Kingdom An agency of the European Union

Author : myesha-ticknor | Published Date : 2014-11-13

europaeu Website wwwemaeuropaeu European Medicines Agency 2013 Reproduction is authorised provided the source is acknowledged 22 May 2013 CHMP43704 Rev 1 Committee

Presentation Embed Code

Download Presentation

Download Presentation The PPT/PDF document " Westferry Circus Canary Wharf London E ..." 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.

Westferry Circus Canary Wharf London E HB United Kingdom An agency of the European Union: 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. 4420 74 18 84 00 Fax 4420 74 18 86 13 Email mailemeaeuropaeu httpwwwemeaeuropaeu European Medicines Agency 2009 Reproduction is authorised provided the source is acknowledged London 19 February 2009 Doc Ref CHMPEWP24095 Rev 1 COMMITTEE FOR MEDICINA europaeu Website wwwemaeuropaeu European Medicines Agency 2013 Reproduction is authorised provided the source is acknowledged 28 June 2013 EMA3857162013 Restrictions on use of codeine for pain relief in ch ildren CMDh endorses PRAC recommendation T 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 (CHMP) REFLECTION PAPER DRAFT AGREED BY BIOSIMILAR MEDICINAL PRODUCTS WORKING PARTY (BMWP) October 2007 KEYWORDS Interferon alfa, recombinant, similar biological medicinal products, comparability, (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 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 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 12 Evaluation of New An ICH PRINCIPLES DOCUMENT FOR CLINICAL EVALUATION OF NEW ANTIHYPERTENSIVE DRUGS TRANSMISSION TO CPMP June 2000 TRANSMISSION TO INTERESTED PARTIES June 2000 This (CHMP) GUIDELINE ON FOLLOW-UP OF PATIENTS ADMINISTERED WITH GENE THERAPY MEDICINAL PRODUCTS AGREED BY GENE THERAPY WP April 2008 AGREED BY PHARMACOVIGILANCE WP March 2008 ADOPTION BY CHMP FOR REL 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 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

Download Document

Here is the link to download the presentation.
" Westferry Circus Canary Wharf London E HB United Kingdom An agency of the European Union"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.