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Session 10 Track 3: How Innovative Collaboration Supports Compliance Across the Regulatory Ecosystem
Session Chair(s)
Karen McCarthy Schau
Sr. Director, Clinical Sciences and Data Integrity, 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)
Paul Cutajar, MA
Director, Innovation & Information Management, Merck & Co., Inc., United States
Compliance through Collaboration Using a Single Business Development Lifecycle Management Tool
Sarah Powell, RAC
President, Powell Regulatory Services, United States
Preparing Your Organization for Transitioning a Digital Dossier
Dominique Lagrave, PharmD
Chief Regulatory Officer, Accumulus Technologies, United States
Working with Health Authorities - The Art of the Possible