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Omni Shoreham Hotel

Sep 22, 2014 8:30 AM - Sep 24, 2014 1:00 PM

2500 Calvert Street NW, , Washington, DC 20008 , USA

EDM and ERS 2014

Session 7 Track 3 - Working with Regional Affiliates to Achieve Compliance Globally

Session Chair(s)

Stacy  Tegan

Stacy Tegan

Program Director

Transcelerate Biopharma, Inc., United States

Learning Objective : - Evaluate the trade-offs between centralized or local RIM tools for regional affiliates - Quantify affiliate time spent on "non-value" work related to RIM tools - Identify what's needed to improve transparency and collaboration between headquarters and regional affiliates

Speaker(s)

Steve  Gens, MS

Global Regulatory Round II: Streamlining and Improving the Local, Regional, and Central Collaboration

Steve Gens, MS

Gens & Associates Inc., United States

Managing Partner

John  Lawrie

How to Design a Global System That Will Be Used and Loved By Regional Affiliates

John Lawrie

Veeva Systems Inc., United States

VP, Vault RIM

Catherine  Mazzrillo, MBA

Thinking Globally, Working Regionally: Opportunities and Challenges Working with Regional Affiliates in a Global World

Catherine Mazzrillo, MBA

Vertex Pharmaceuticals, United States

Associate Director, Regulatory Submission Management

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