Visit www.brookwood-global.com for further details and to order online • OUR E-BOOKS • GCLP Regs RM MD NIS CDM PV GDPR GCP Indexed ICH GCP Guidelines with Integrated Addendum E6(R2) Step 4, November 2016 European Clinical Trial Regulation 536/2014 with unique subject index FIRST EDITION Key Requirements Affecting Clinical Trials in Europe FIFTH EDITION Indexed ICH GCP E6(R2) Guidelines This publication contains a uniquely indexed version of the ICH Harmonised Guideline entitled “Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2)”. It was published by ICH in November 2016 and has now reached Step 5 in many regions and countries. Brookwood’s unique subject index allows easy navigation to the required sections. ISBN: 978-1-912055-54-8 Price Band: A European Clinical Trial Regulation 536/2014 A uniquely indexed reproduction of the European Clinical Trial Regulation 2014 No. 536 as published in the Official Journal on 27 May 2014. The unique Brookwood index of subject headings and key words helps users find the appropriate sections quickly and easily. The index also cross-references the Clinical Trials Directive 2001/20/EC, the Declaration of Helsinki and ICH GCP. ISBN: 978-1-912055-68-5 Price Band: B Key Requirements Affecting Clinical Trials in Europe (5th Edition) This publication combines the key requirements and guidelines with a unique subject index that allows the user to search for the appropriate sections using key words. It brings together the globally accepted ICH GCP E6(R2) guidelines, the three major EU Directives affecting clinical trials – Directive 2001/20/EC (including amendments since 2001), Directive 2005/28/EC, Directive 2003/94/EC – Annex 13 (July 2010) relating to investigational medicinal products and both the 1996 and 2013 versions of the Declaration of Helsinki. ISBN: 978-1-912055-71-5 Price Band: B Click for product demo Click for product demo Click for product demo
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