Autumn Introductory Course 2017 - Day 1

21/11/2017

Time lines for XEVMPD and IDMP

Integrating eSolutions

Proper use of eSubmissions increases ● Consistency ● Transparency ● Speed Requires ● Technical interoperability (=hardware, software and infrastructure) ● Semantic interoperability (=taxonomy) ● Organisational interoperability (=harmonised processes) ● And …………………. You! Compliance and reliability

XEVMPD update: 31 December 2014 IDMP Iteration 1 EU: >2019 IDMP US: being included in various other electronic requirements

PLAN AHEA

Now

>2019

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November 2017

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The Learning Objectives for this presentation were:

Thank you for listening! Questions? Hans van Bruggen hbruggen@ectdconsultancy.com

See regulatory content in perspective of the purpose of a regulatory dossier See a regulatory dossier as justification for a drugs quality, and efficacious and safe use by appropriate users Understand the difference between product-, document- and dossier lifecycle Understand why validation of the dossier is key Explain the difference between technical- and business validation Awareness about the current XEVMPD and near future IDMP Requirements for integrating eSolutions

November 2017

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November 2017

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