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Regulatory Submissions, Information, and Document Management Forum

Session 5 Track 2: IDMP Technology Focus

Session Chair(s)

Vada A. Perkins, DrSc, MSc

Vada A. Perkins, DrSc, MSc

  • Executive Director, Regulatory Policy and Intelligence
  • Bayer Pharmaceuticals, United States

Explore the alignment of IDMP and existing standards and processes within the regulatory landscape: (e) CTD maintenance, ICSR, and CDISC standards respectively. Discussion topics include how companies can leverage change control and regulatory impact analyses outcome for IDMP maintenance; the structure of the ISO/HL7 Individual Case Safety Report specification, how it supports multiple surveillance programs, improves data quality and reconciles pre- and post-market safety data; and the upcoming B2E project that will bring CDISC standards into compliance with IDMP, including protocol and results registration and how IDMP extends the substance and product information within the SEND and SDTM standards.

Learning Objective : Define the challenges of including all relevant information updates in your IDMP submissions, demonstrate practical concepts for automation of the process of IDMP submission outline verification and align information in the CTD documentation, administrative documents and IDMP submission.

Speaker(s)

Michiel Stam

IDMP Driven Revisit of Change Control and Impact on EU Variation Classification Document

Michiel Stam

  • Head of Data Management and Regulatory Information Scientist
  • Qdossier, Netherlands
Lise Stevens

A Case Study in ICSR and IDMP Integration: Electronic Adverse Event Reporting Systems

Lise Stevens

  • Prinicpal Owner
  • Saturn Services LLC, United States
Paul Houston

CDISC Beginning to End Standards Harmonized with IDMP and Extending CTR and Protocol

Paul Houston

  • CDISC Europe - Head of European Operations
  • CDISC, France