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Session 10 Track 3: How Innovative Collaboration Supports Compliance Across the Regulatory Ecosystem
Session Chair(s)
Karen McCarthy Schau
Director, Risk-based Study Management
Vertex Pharmaceuticals, United States
The way industry works with health authorities has not changed significantly since the introduction of electronic submissions and has impacted communications and responsibilities across functions. This session will explore ways sponsors can achieve both greater control and compliance as well as improving their way of working together with health authorities to expand access to medicines.
Learning Objective : At the conclusion of this session, participants should be able to:- Outline the collaborative benefits for compliance using a BDL solution
- Explain how the organization can better collaborate with Health Authorities during the review process
- Identify if their organization is ready to explore structure content authoring
Speaker(s)
Compliance through Collaboration Using a Single Business Development Lifecycle Management Tool
Paul Cutajar, MA
Merck & Co., Inc., United States
Director, Innovation & Information Management
Preparing Your Organization for Transitioning a Digital Dossier
Sarah Powell, RAC
Powell Regulatory Services, United States
President
Working with Health Authorities - The Art of the Possible
Dominique Lagrave, PharmD
Accumulus Synergy, United States
Senior Vice President of Regulatory Innovation
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