Scientific advice and protocol assistance: Regulatory and procedural guidance

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This page lists the guidance for companies seeking scientific advice or protocol assistance.

Table of contents

Guidance for companies

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Document(s) Language Status First published Last updated Effective Date
CHMP protocol assistance scientific advice briefing document template (English only)   18/06/2010    
The dates of 2012 Scientific Advice Working Party meetings and deadlines for scientific advice or protocol assistance request submissions (English only) adopted 12/10/2010 09/12/2011  
The dates of 2011 SAWP meetings and deadlines for scientific advice or protocol assistance request submissions (English only) adopted 12/10/2010    
The dates of 2010 SAWP meetings and deadlines for scientific advice or protocol assistance request submissions (English only)   19/06/2009 12/10/2010  
European Medicines Agency guidance for companies requesting scientific advice and protocol assistance (English only)   22/01/2009 06/07/2010  
Template letter of intent for request of scientific advice or protocol assistance (English only)   03/11/2009 10/01/2012  
General principles: European Medicines Agency-Food and Drug Administration parallel scientific advice (English only)   22/07/2009    
New framework for scientific advice & protocol assistance (English only) adopted 26/04/2006    
Overview of responses received from interested parties and EMEA recommendations on the new framework for scientific advice & protocol assistance (English only)   25/04/2006    

Standard operating procedures and work instructions

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Document(s) Language Status First published Last updated Effective Date
Standard operating procedure for scientific advice and protocol assistance procedure (English only) adopted 01/07/2008   01/07/2008
Work instructions for general dealings between SAWP secretariat and working parties, SAGs, committees and patients' organisations (English only) adopted 24/11/2009   26/11/2009
Work instructions for organisation of Scientific Advice Working Party meetings (English only) adopted 28/07/2008 01/07/2010 28/07/2008
Work instructions for organisation of scientific advice and protocol assistance pre-submission meetings (English only) adopted 01/07/2008   01/07/2008
Work instructions for organisation of discussion meetings for scientific advice and protocol assistance (English only) adopted 03/07/2008 15/05/2012 16/05/2012
Work instructions for validation of scientific advice and protocol assistance requests (English only) adopted 03/10/2008   03/10/2008
Work instructions for scientific advice/protocol assistance peer review (English only) adopted 05/03/2009   05/03/2009
Work instructions for nomination of co-ordinators for scientific advice and protocol assistance (English only) adopted 01/07/2008 08/05/2012 07/05/2012
Work instructions for finalisation of scientific advice and protocol assistance letters (English only) adopted 24/10/2008 15/03/2010 15/03/2010
Work instructions for scientific advice and protocol assistance master file (English only) adopted 01/07/2008   01/07/2008
Work instructions for use of scientific advice and protocol assistance database (English only) adopted 06/10/2008   06/10/2008