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Bethesda North Marriott Hotel and Conference Center

Feb 08, 2016 12:00 PM - Feb 10, 2016 5:15 PM

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

Regulatory Submissions, Information, and Document Management Forum

Discuss the end-to-end process for document management, publishing, and technical regulatory requirements in regulatory information management.

Session 3 Track 4 - An Agile Approach Towards Implementing IDMP Technologies

Session Chair(s)

Michiel  Stam

Michiel Stam

Director Regulatory Information Management

Qdossier - A Celegence Company, United Kingdom

Documents containing IDMP information exist of natural language and allow for semantic differences. In practice this results in inconsistent and/or out-of-sync information across data containers, disciplines, regions, and products. The general belief is that managing information in a structured format should tackle these challenges and offer new opportunities to reuse data without rework. One of the hallmarks of IDMP will be moving product information from unstructured, document-bound information to more structured environments, enabling structured content management. This session will focus on extracting text from unstructured sources, as well as planning for never having to do that again using structured document authoring. Furthermore, it discusses how information stored in a huge amount of documents can be analysed and normalised according to a common terminology.

Learning Objective : Describe additional IDMP Benefits beyond compliance Outline opportunities and components that should be considered as part a future roadmap Identify related impact areas and key stakeholder groups

Speaker(s)

Marcel  Lissinna

Global IDMP Journey - Alignment of Structured and Unstructured Data Provide Opportunities to Drive Value Beyond Compliance

Marcel Lissinna

Deloitte Consulting, United States

Specialist Leader

Michiel  Stam

From Documents to Data: Extraction and Transformation to Standard Terminology

Michiel Stam

Qdossier - A Celegence Company, United Kingdom

Director Regulatory Information Management

Joel  Finkle

Building the IDMP-Agile Enterprise

Joel Finkle

Retired, United States

Industry Expert

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