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Bethesda North Marriott Hotel and Conference Center

2017年2月06日 (月) 午前 7:00 - 2017年2月08日 (水) 午後 5:00

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Regulatory Submissions, Information, and Document Management Forum

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Session 5 Track 2: IDMP Technology Focus

Session Chair(s)

Vada Perkins, DRSC, MSC

Vada Perkins, DRSC, MSC

Vice President, Global Head of Regulatory Intelligence & Policy

Boehringer Ingelheim, 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

MAIN5 Gmbh & Co. Kgaa, Germany

Management Consultant

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

Lise Stevens

Saturn Services LLC, United States

Prinicpal Owner

Paul Houston

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

Paul Houston

CDISC, France

CDISC Europe - Head of European Operations