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Bethesda North Marriott Hotel and Conference Center

05 feb 2018 7:00 a.m. - 07 feb 2018 3:00 p.m.

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

Regulatory Submissions, Information, and Document Management Forum

Session 7 Track 1: Paradigm Shift in Data Management and How to Enrich Business Intelligence to Benefit the Industry

Session Chair(s)

Brooke  Casselberry, MS, RAC

Brooke Casselberry, MS, RAC

Vice President, Advisory and Delivery

Epista Life Sciences, United States

This session cover case studies from three top biopharmaceutical companies and how they are changing the way they use data in their organizations. You will learn how organizations are using data and standards in more expansive ways. You will hear directly from peers on the steps taken to change the current thinking in their organizations on data, RIM, IDMP, and overall standards.

Learning Objective : Upon completion of this session, the participant should be able to:
  • Learn how organizations are using data and standards in more expansive ways
  • Hear directly from peers on the steps taken to change the current thinking in their organizations on data, RIM, IDMP, and overall standards
  • Discuss how to change their system, data, and user interface approach from being an administrative activity to an analytical activity

Speaker(s)

Kelly  Hnat

Case Study – Implementing a Paradigm Shift in RIM Data Management: From Administrative Afterthought to Strategic Asset

Kelly Hnat

K2 Consulting/Gens & Associates, United States

Principal

Andrea  Herrmann, PharmD

Case Study – Improvement of Collaboration Across Industries

Andrea Herrmann, PharmD

Merck Healthcare KGaa, Germany

Head of Regulatory Compliance & Regulatory Information Management

John  Stanek

Case Study – Enhanced Planning for Due Diligence and M&A Using the ISO IDMP Data Model

John Stanek

Johnson & Johnson Group of Consumer Companies, United States

Sr. Associate, Global Regulatory Affairs

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