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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

Overview

Regulatory Submissions, Information, and Document Management Forum

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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Short Course 2: The Future of Regulatory Affairs

Overview

Learning objectives

Be informed and stay engaged.