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Bethesda North Marriott Hotel and Conference Center

Feb 11, 2019 8:30 AM - Feb 11, 2019 12:00 PM

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

Short Course 2: The Future of Regulatory Affairs


Short Course Registration: 8:00-9:00AM

During this course the instructors will show how the ongoing and future transformation of regulatory affairs leads to well defined end-to-end business processes. These processes ensure consistent and efficient use of information across documents, data, and dossiers. This is shown by real life examples from various pharma companies. Participants will also learn about best practices for data-, document- and dossier-management.

Learning objectives

At the conclusion of this short course, participants should be able to:
  • Define what the future RA processes and workflows must look like
  • Identify how RA decision making must be supported by interconnected data, documents and dossiers
  • Define lean and reliable E2E Regulatory workflows
  • Describe the future roles within the RA department
  • See how transformation cannot be driven by technological advancements only
  • Distinguish between content and contextual information
  • Explain the importance of authoring stand-alone components
  • Define document granularity and cross-referencing best practices
  • Appraise the role of semantics in information management

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