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Session 8 Track 3: Creating and Streamlining Regulatory Dossier Management
Session Chair(s)
Cindy Chiu
Senior Director, Regulatory Affairs Operations and Quality Management
Merck & Co., Inc., United States
This session will provide tried-and-tested methods for creating and streamlining regulatory dossier management. This includes a deep dive into the implementation of a cloud-based EDMS at a small biotech how it established a 'one stop shop' for regulatory content reporting and tracking. Also, learn leading practices for expanding regulatory initiatives across the globe by taking a single-dossier approach to product registrations. This session provides strategies on communication, project management, and content management to expedite your product approval projects across the world.
Learning Objective : Upon completion of this session, the participant should be able to:
- Explain how a cloud-based EDMS can keep a company agile as they grow in associate numbers, pipeline, and global presence
- Plan, organize, and distribute the content of Regulatory Dossiers efficiently across the globe
- Integrate project management best practices into registration strategy
Speaker(s)
Designing and Implementing an Integrated Regulatory Experience
Richard Fredericks, MBA
Mersana Therapeutics, United States
Senior Director, Regulatory Operations and Technology
Take a Global Approach to Regulatory Dossier Management
Alex Butler, MBA
MasterControl, United States
Product Marketing Manager
Speaker
Lillian Erickson
Stryker, United States
Quality Manager - Acute Ischemic Stroke