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2016 年 02 月 08 日 12:00 下午 - 2016 年 02 月 10 日 5:15 下午

Regulatory Submissions, Information, and Document Management Forum

Session Chair(s)

Sarah  Powell, RAC

Sarah Powell, RAC

President, Powell Regulatory Services, United States

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

Speaker(s)

Joe  Shepley, PHD, MA

Joe Shepley, PHD, MA

Managing Director, Ankura, United States

Quality by Design and the Strategic Transformation of Regulatory Operations

Christopher P Hanna, PHD, PMP

Christopher P Hanna, PHD, PMP

Principal, Kattner-Thalmann Partners, United States

Speaker

Elizabeth M Turek

Elizabeth M Turek

Head, Knowledge Management, Johnson & Johnson, United States

The Future Regulatory Operations Organization

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