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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 1 - Next Generation Regulatory Operations

Session Chair(s)

Sarah  Powell, RAC

Sarah Powell, RAC


Powell Regulatory Services, United States

Many Regualtory Operations organizations suffer from the same set of problems. Learn how Regulatory Operations organizations are looking to transform themselves and become more strategic partners within their organizations.

Learning Objective : 1. Recognize the challenges facing the life sciences industry specific to Regulatory Operations 2. Identify the main components of Quality by Design (QBD) 3. Apply core QBD principles and approaches to their day-to-day work in Regulatory Operations


Joe  Shepley, PhD, MA

Quality by Design and the Strategic Transformation of Regulatory Operations

Joe Shepley, PhD, MA

Ankura, United States

Managing Director

Christopher P Hanna, PhD, PMP


Christopher P Hanna, PhD, PMP

Kattner-Thalmann Partners, United States


Elizabeth M Turek

The Future Regulatory Operations Organization

Elizabeth M Turek

Johnson & Johnson, United States

Head, Knowledge Management

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