IDMP data collection from documents - Strategies towards IDMP compliance.


Joel Finkle is Director, Regulatory Innovation and IDMP Strategy for ACUTA. In this role he brings new technologies and regulatory data standards to ACUTA's bio/pharmaceutical customers to ensure compliance and process improvements. Currently, this involves bringing the IDMP (Identification of Medicinal Products) and eCTD (electronic Common Technical Document) version 4.0 standards into our products and services, as well as providing the focal point within the company for other industry standards and regulatory guidance. Mr. Finkle comes from a background in the Pharmaceutical industry and wit........

Overview

This session will review the basic requirements of the initial planned European implementation of the ISO IDMP standard, then explore how the data for a product could be gathered for entry into a RIM system or what is expected in the agency web portal. Benefits of integration in a RIM environment, and downstream use of the data, will be covered.

Why should you attend this webinar?

Compliance with IDMP is not expected for a couple years, but the amount of preparation for existing products is extensive. Getting ahead of the deadlines will make compliance possible, while adding value by codifying the data found in company documentation. The downstream use of IDMP data for regulatory intelligence, marketing and supply chain will also add value to your company.

Areas Covered in the Session:

  • ISO IDMP Standard Overview
  • European Medicines Agency (EMA) Implementation Plans and Progress
  • Mapping data from XEVMPD to IDMP
  • Gathering details from the Summary of Product Characteristics (SMPC)
  • Completing the European Requirements from submissions and other documentation

Who can Benefit:

Regulatory Operations Staff and Management
Regulatory Affairs Staff and Management


Webinar Id: LSHCJI001

Training Options:

Duration: 60 mins

  23-Jan-2018

 12.30 PM PT | 03.30 PM ET

 Single Attendee: [Only for one participant]

$179 (Live)                    $319 (Live + Recorded)

 Multiple Attendee: [For a group of 2-5 participants]

$368 (Live)                    $495 (Live + Recorded)

 Corporate Attendee: [For a group of 6-10 Participants]

$741 (Live)                    $1157 (Live + Recorded)

 Recorded: [Six month unlimited access]

$167 (Single Attendee) $599 (Unlimited Attendee)

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