Search results with tag "Granularity"
CTD: Revisions to the M4 Granularity Document
www.ich.org1/23/2017 2 3 Outline • Who is the CTD-Q IWG • Background • Objective of the Guideline Revision • Scope/Content of the Guideline Revision • Implementation of the Guideline Revision • Conclusion CTD: Revisions to the M4 Granularity Document 4 Background • 1994: o M2: “Electronic Standards for the Transfer of Regulatory Information” (ESTRI) EWG established
Industry Book of Knowledge - Triphase Pharma …
www.triphasepharmasolutions.comQuality Overall Summary (QOS) in eCTD format 2010 5 QOS eCTD/CMC v1.2 March 24, 2010 1. Granularity for Quality Overall Summary The ICH Guidance “Granularity Document Annex to M4: Organization of the CTD” outlines three
Granularity Adjustment for Regulatory Capital Assessment
www.ijcb.orgGranularity Adjustment for Regulatory Capital Assessment∗ Michael B. Gordya and Eva L¨utkebohmertb aFederal Reserve Board bUniversity of Freiburg The credit value-at-risk model underpinning the internal ratings-based approach of Basel II and III assumes that idio-