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Session 5 Track 2: IDMP Technology Focus
Session Chair(s)
Vada Perkins, DrSc, MSc
Vice President, Global Head of Regulatory Intelligence & Policy
Boehringer-Ingelheim, 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
Qdossier - A Celegence Company, United Kingdom
Director Regulatory Information Management
A Case Study in ICSR and IDMP Integration: Electronic Adverse Event Reporting Systems
Lise Stevens
Saturn Services LLC, United States
Prinicpal Owner
CDISC Beginning to End Standards Harmonized with IDMP and Extending CTR and Protocol
Paul Houston
CDISC, France
CDISC Europe - Head of European Operations
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