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Session 10 Track C: Global Strategies for Global Submissions
Session Chair(s)
Robin Whitsell
President
Whitsell Innovations, Inc., United States
Increasingly submissions are planned across multiple geographies simultaneously, creating a burden on resource-constrained teams and their medical writers. This session will engage the audience with best practices based on successful global submissions and lessons learned from complex submissions. It will focus on coordinated planning and preparation of briefing packages. We will present a case study of a large, global submission and share perils and pearls. Come with questions and stories to share.
Learning Objective : At the conclusion of this session, participants should be able to:
• Articulate the importance of strategic planning and identify and sequence steps towards successful completion
• Differentiate the best approaches for briefing packages submitted to various global regulatory authorities
• Discuss the lessons learned from a large global submission based upon a case study presented
Speaker(s)
Faculty
Robin Whitsell
Whitsell Innovations, Inc., United States
President
Faculty
Sarah Duban, MA
AbbVie Inc., United States
Assistant Director, Medical Writing
Faculty
Dominic De Bellis, PhD
Boehringer Ingelheim Pharmaceuticals, Inc., United States
Senior Associate Director, US Medical Writing
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