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Hotel Holiday Inn

May 23, 2016 9:00 AM - May 23, 2016 5:30 PM

Haagse Schouwweg 10, 2332 KG Leiden, Netherlands

TUTORIAL 2 - REGULATORY INFORMATION MANAGEMENT AND IDENTIFICATION OF MEDICINAL PRODUCTS (IDMP)

Overview

REGULATORY INFORMATION MANAGEMENT AND IDENTIFICATION OF MEDICINAL PRODUCTS (IDMP)

Co-Instructors:

  • Frits Stulp, IDMP Program Manager, Astellas Pharma, Netherlands
  • JasperRiksen, XEVMPD / IDMP Consultant, Astellas Pharma, Netherlands
  • Michiel Stam, Regulatory Operations Scientist, eCTDconsultancy, Netherlands

    The implementation of IDMP in the EU is now gathering pace with agreements on the scope of Iteration 1 for Authorised Medicinal Products, on Organisation information and how Controlled Vocabularies will be managed. The scope of Iteration 1 is greater than that of XEVMPD and will bring some challenges in obtaining and maintaining data. Companies will need to address how they manage these challenges, in the shorter-term for Iteration 1 and in the longer-term for subsequent iterations which will have much wider scope and be significantly more complex to address. The tutorial will address the shorter-term requirements for Iteration 1 and the longer-term strategic needs of managing IDMP data for regulatory compliance, use in healthcare scenarios and for internal business benefit and efficiency.

    Discussion topics will include:

  • Status of implementation of IDMP implementation in EU (and other regions)
  • Medicinal Product data for Iteration 1 (e.g. differences from XEVMPD, challenges)
  • Impacts of requirements for Substances, Organisations and managing Controlled Vocabularies
  • Implementing IDMP – case examples including building the business case
  • Strategic approaches to IDMP data management (RIM, MDM, EDM, RDM, Structured Content Authoring)

    Target Audience

    Professionals involved in the following areas:
  • Regulatory Information Management
  • Regulatory Information Technology
  • Reference- and Master Data Management
  • Supply Chain
  • XEVMPD
  • Pharmacovigilance
  • Quality Assurance
  • Standardisation and Harmonisation
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