PDF-European Medicines Agency 7 Westferry Circus, Canary Wharf, London, E1
Author : briana-ranney | Published Date : 2016-05-22
CHMP REFLECTION PAPER ON METHODOLOGICAL ISSUES IN CONFIRMATORY CLINICAL TRIALS PLANNED WITH AN ADAPTIVE DESIGN DRAFT AGREED BY THE EFFICACY WORKING PARTY 11 January
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European Medicines Agency 7 Westferry Circus, Canary Wharf, London, E1: Transcript
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. 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 2014 Reproduction is authorised provided the s ource is acknowledged 26 May 2014 EMA1615302014 Inspections and Human Medicines Pharmacovigilance Division DRAFT etailed uid regarding the onit 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 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 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 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 NOTE FOR GUIDANCE ON STABILITY TESTING: STABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS (CPMP/ICH/2736/99) SION TO CPMP November 1999 RELEASE FOR CONSULTATION November 1999 DEADLINE FOR COM On 19 February 2009, Denmark (DK) presented to the EMEA a request for a CHMP opinion under Article 5(3) of Regulation (EC) No 726/2004 to Currently, medicinal products authorised in the European Union ICH Topic Q 5 D Quality of Biotechnological Products: Derivation and Characterisation of Cell Substrates Used for Production of Biotechnological/Biological Products Step 5NOTE FOR GUIDANCE ON QUALI ICH Topic Q 5 B Quality of Biotechnological Products: Analysis of the Expression Construct in Cell Lines Used for Production of r-DNA Derived Protein Products NOTE FOR GUIDANCE ON QUALITY OF BIOTE 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
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