Chmp PowerPoint Presentations - PPT

22 MayEMA/CHMP/BWP/247713/2012Committee for Medicinal Products for Hum
22 MayEMA/CHMP/BWP/247713/2012Committee for Medicinal Produc - pdf

mitsue-sta

Adoption by CHMP for release for consultation24 May 2012 Start of public consultation31 May 2012 End of consultation (deadline for comments)30 November 2012 Revised draft agreed by BMWP and BWPApril 2

21 February 2013EMA/CHMP/BMWP/652000/2010Committee for Medicinal Produ
21 February 2013EMA/CHMP/BMWP/652000/2010Committee for Medic - pdf

test

Adoption by CHMP for release for consultationOctober 2011 End of consultation (deadline for comments)31 March 2012 Agreed by BMWPJanuary Date for coming into effect01 September 2013 Interferon beta,

February 2014EMA/MB//201NotedManagement Board meeting of 20 MarchOutco
February 2014EMA/MB//201NotedManagement Board meeting of 20 - pdf

celsa-spra

memberships in the CHMP and CVMP. Renewed memberships include also those memberships where 7 Westferry Circus Canary Wharf London E14 4HB United KingdomAn agency of the European Union Telephone Cou

 June  EMACHMP Committee for Medicinal Products for Human Use CHMP Guideline on
June EMACHMP Committee for Medicinal Products for Human Us - pdf

calandra-b

1 10 Comments should be provided using this template The completed comments form should be sent to CVSWPSecretariatemaeuropaeu 11 12 Keywords Obesity weight control guidance 13 7 Westferry Circus Canary Wharf London E14 4HB United Kingdom An agency

January 2015EMA/CHMP/ICH/353369/2013ICH guideline Q3D elemental impuri
January 2015EMA/CHMP/ICH/353369/2013ICH guideline Q3D elemen - pdf

karlyn-boh

End of consultation (deadline for comments)31 December 2013 Final adoption by CHMPDecember 2014 Date for coming into effectFor new marketing authorisation applications: Scope:The guideline applies to

10 NovemberEMA/CHMP/SAWP/72894/2008Revision 1: January 2012Revision 2:
10 NovemberEMA/CHMP/SAWP/72894/2008Revision 1: January 2012R - pdf

debby-jeon

Adoption by CHMPfor release for consultation24 April 2008 End of consultation (deadline for comments)30 June 2008 Final Agreed by CHMP22 January 2009 Keywords EMA . CHMP. Novel methodology. Q ualifica

January 2015EMA/CHMP/ICH/353369/2013ICH guideline Q3D elemental impuri
January 2015EMA/CHMP/ICH/353369/2013ICH guideline Q3D elemen - pdf

cheryl-pis

End of consultation (deadline for comments)31 December 2013 Final adoption by CHMPDecember 2014 Date for coming into effectFor new marketing authorisation applications: Scope:The guideline applies to

European Medicines Agency 7 Westferry Circus, Canary Wharf, London, E1
European Medicines Agency 7 Westferry Circus, Canary Wharf, - pdf

conchita-m

(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

April1 EMA/CHMP/281825/20152 Committee for Human Medicinal Products HM
April1 EMA/CHMP/281825/20152 Committee for Human Medicinal P - pdf

alida-mead

Adoptedby CHMPfor release for consultation art of public consultation13 May 2015 End of consultation (deadline for comments)November 2015 7 This guideline replaces 'Guideline on clinical devel

European Medicines Agency  7 Westferry Circus, Canary Wharf, London, E
European Medicines Agency 7 Westferry Circus, Canary Wharf, - pdf

briana-ran

(CHMP) REFLECTION PAPER DRAFT AGREED BY BIOSIMILAR MEDICINAL PRODUCTS WORKING PARTY (BMWP) October 2007 KEYWORDS Interferon alfa, recombinant, similar biological medicinal products, comparability,

European Medicines Agency 7 Westferry Circus, Canary Wharf, London, E1
European Medicines Agency 7 Westferry Circus, Canary Wharf, - pdf

briana-ran

(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

European Medicines Agency Pre-authorisation Evaluation of Medicines fo
European Medicines Agency Pre-authorisation Evaluation of Me - pdf

calandra-b

(CHMP) GUIDELINE ONTHE CHOICE OF THE NON-INFERIORITY MARGIN DRAFT AGREED BY THE EFFICACY WORKING PARTY ADOPTION BY COMMITTEE FOR RELEASE FOR CONSULTATION February 2004 AGREED BY WORKING PARTY June

European Medicines Agency Evaluation of Medicines for Human Use7 Westf
European Medicines Agency Evaluation of Medicines for Human - pdf

sherrill-n

(CHMP) SEALANT/HAEMOSTATIC PRODUCTS (CPMP/BPWG/153/00) DISCUSSION IN THE BLOOD PRODUCTS WORKING GROUP DISCUSSION IN THE PHARMACOVIGILANCE WORKING PARTY April 2001 TRANSMISSION TO THE CPMP Decembe

uropean Medicines Agency Inspections  7 Westferry Circus, Canary Wharf
uropean Medicines Agency Inspections 7 Westferry Circus, Ca - pdf

debby-jeon

EMEA/CHMP/QWP/49313/2005 Corr EMEA 2006 Page 2/27 GUIDELINE ON THE PHARMACEUTICAL QUALITY OF INHALATION AND NASAL PRODUCTS TABLE OF CONTENTS 1. INTRODUCTION........................................

uropean Medicines Agency Evaluation of Medicines for Human Use   7 Wes
uropean Medicines Agency Evaluation of Medicines for Human U - pdf

kittie-lec

EMEA/CHMP/BMWP/31329/2005 Page 2/6 EMEA 2006 TABLE OF CONTENTS EXECUTIVE SUMMARY...................................................................................................................3

 May  EMACHMPBWP Committee for Medicinal Produc ts for Human Use CHMP Guideline on similar biological medicinal products containing biotechnology derived proteins as active substance quality issues re
May EMACHMPBWP Committee for Medicinal Produc ts for Human - pdf

karlyn-boh

europaeu Website wwwemaeuropaeu European Medicines Agency 2014 Reproduction is authorised provided the source is ac knowledged Guideline on similar biological medicinal products containing biotechnology derived proteins as active substance quality

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