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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
- Executive Director, Regulatory Policy and Intelligence
- Bayer Pharmaceuticals, United States
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)
IDMP Driven Revisit of Change Control and Impact on EU Variation Classification Document
Michiel Stam
- Director Regulatory Information Management
- Qdossier - A Celegence Company, Netherlands

A Case Study in ICSR and IDMP Integration: Electronic Adverse Event Reporting Systems
Lise Stevens
- Prinicpal Owner
- Saturn Services LLC, United States
CDISC Beginning to End Standards Harmonized with IDMP and Extending CTR and Protocol
Paul Houston
- CDISC Europe - Head of European Operations
- CDISC, France