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Session 8 Track 4: Achieving a Global Dossier: How Can Industry Encourage Convergence and Collaboration to Revolutionize Regulatory Review?
Session Chair(s)
Katherine Novak, MS
Principal Consultant
Epista Inc., United States
This session will focus on the vision for a global dossier and how reliance principles reduce review timelines by encouraging collaboration across regulatory authorities and reducing duplicate effort and complexity of questions. Two industry case studies will be presented. Speakers will highlight the strategic approach for convergence, practical considerations, and success metrics for global and regional reviews.
Learning Objective : - Understand how industry can successfully execute “one dossier” initiatives
- Understand Reliance principles and how this impacts regulatory strategy and operations
- Define practical use cases that can have immediate impact towards the long term vision of a global dossier
- Assess industry's role in accelerating convergence and collaboration across regulatory agencies
Speaker(s)
Ignite the Future - Our Exciting PAC Reliance Journey with 48 NRAs
Francesca Mangia, PhD
F. Hoffmann-La Roche Ltd, Switzerland
Regulatory Affairs International Operations Manager
Establishing a Core Dossier for Multiple Regulatory Submissions: A Case Study in the Latin America Region
Omar Ruiz
Pfizer, United States
Sr. Director Regulatory Affairs
Speaker
Nélio Cézar de Aquino, MSc
ANVISA, Brazil
General Manager of Medicines
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