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Technical Regulatory Standards

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Introduction to CMC Regulatory Affairs - Mamidipudi

www.ispeboston.org

Nov 10, 2016 · Types of Regulatory dossiers: 9 Connecting Pharmaceutical Knowledge ispe.org Format of Regulatory dossier CTD- Common Technical document 10 ICH M4Q (R1) proposes the CTD format for all the regulatory dossiers. The CTD format has 5 modules Module 1- Regional Information includes forms and country specific requirements Module 2: provides …

  Regulatory, Technical

Technical standards under Directive 2004/39/EC (MiFID I ...

ec.europa.eu

Technical standards under Directive 2004/39/EC (MiFID I), Directive 2014/65/EU (MiFID II) and Regulation (EU) No 600/2014 (MiFIR) (last updated: 01/02/2017) 3 The volume cap mechanism and the provision of information for the purposes of transparency and other calculations MiFIR Articles 5(9) and 22(4) 13/06/2016 C(2016) 2711 13/09/2016

  Standards, Technical, Technical standards, Mifid

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