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Bethesda North Marriott Hotel and Conference Center

Feb 12, 2024 8:00 AM - Feb 14, 2024 2:30 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Regulatory Submissions, Information, and Document Management Forum

Don't miss the latest trends, innovations, and best practices in regulatory submissions, information, and document management (RSIDM)!

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

Katherine Novak, MS

Principal Product Manager

Accumulus Synergy, 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


Francesca  Mangia, PhD

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

Omar  Ruiz

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

Nélio Cézar  de Aquino, MSc


Nélio Cézar de Aquino, MSc

ANVISA, Brazil

General Manager of Medicines

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