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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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 2008-07-01 2015-12-03 2015-12-01
Work instructions for general dealings between SAWP secretariat and working parties, SAGs, committees and patients' organisations (English only) adopted 2009-11-24   2009-11-26
Work instructions for organisation of Scientific Advice Working Party meetings (medicines for human use) (English only) adopted 2008-07-28 2013-06-11 2013-06-11
Work instructions for organisation of scientific-advice and protocol-assistance presubmission meetings (English only) adopted 2008-07-01 2013-06-24 2013-06-24
Work instructions for organisation of discussion meetings for scientific advice and protocol assistance (English only) adopted 2008-07-03 2012-05-15 2012-05-16
Work instructions for validation of scientific advice and protocol assistance requests (English only) adopted 2008-10-03   2008-10-03
Work instructions for scientific-advice / protocol-assistance peer review (English only) adopted 2009-03-05 2013-05-03 2013-05-06
Work instructions for nomination of co-ordinators for scientific advice and protocol assistance (English only) adopted 2008-07-01 2012-05-08 2012-05-07
Work instructions for finalisation of scientific-advice and protocol-assistance letters (English only) adopted 2008-10-24 2013-01-10 2013-01-10
Work instructions for use of scientific-advice and protocol-assistance database (English only) adopted 2008-10-06 2013-06-24 2013-06-24