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

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Adoption by CHMPfor release for consultation24 April 2008 End of consultation deadline for comments30 June 2008 Final Agreed by CHMP22 January 2009 Keywords EMA

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10 NovemberEMA/CHMP/SAWP/72894/2008Revision 1: January 2012Revision 2:: Transcript

Adoption by CHMPfor release for consultation24 April 2008 End of consultation deadline for comments30 June 2008 Final Agreed by CHMP22 January 2009 Keywords EMA CHMP Novel methodology Q ualifica. 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 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 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 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 (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 30 07/11/201411/13/2008Revision:Supersedes Revision:07/21/2014Printed: * Key wordGHS hazard phraseAspiration Toxicity, Category 1DangerAquatic Toxicity (Acute), Category 3noneAquatic Toxicity (Chronic 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 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 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, (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 Page 3/5Printing date 02.04.2008Revision: 02.04.2008Trade nameCementitious powder products with no identification requirements, 1(Contd. of page 2) No further data; see item 7.Components with critical 8 Week Quilt JourneyDaytime:Wednesdays, January 18, 25; February 1, 15, 22; March 8, 15, 22 (8 sessions) from 10:30am-12:30pmEvening:Wednesdays, January 18, 25; February 1, 15, 22; March 8, 15, 22 (8 ContentsInstructions for users1 What is the legal basis of scientific advice2 What is the legal basis of protocol assistance3 What falls under the scope of scientific advice and protocol assistancePot Canary⁗harf London⁅14‵EU An⁡gency⁯f⁴he⁅uropean⁕nion† Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/co ntact 2019 .

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