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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 11 Track 2: Optimizing Submission Filings: Understanding the Challenges and Developing Strategies Accelerating Submission Delivery to Health Authorities

Session Chair(s)

Teresa  Martins

Teresa Martins

Senior Director, US Site Head Regulatory Submission Management

Bayer U.S. LLC, United States

Regulatory is on the critical path to launch and valuable time can be saved or lost during the final stage before handing the submission over to health authorities for review. This session provides insight regarding the accelerating of the submission timeline, proactive publishing strategies for mitigating document re-work, and management of label content. All efficiencies presented will focus on ensuring content consistency across the product lifecycle and different regions, maintaining submission compliance and quality, and preventing potential risks to patient safety.

Learning Objective :
  • Identify a range of tools, for accelerating average submission times to get safe and effective medicines to the patient faster
  • Describe real-world examples for mitigating publishing re-work and ways to increase efficiency
  • Recognize the significant impact of a centralized digital label management platform on improving automatic tracking and managing of different label versions across different markets


Patterson  Shafer

A Multi-faceted Approach to Achieving Faster Filings

Patterson Shafer

FTI Consulting, Inc., United States

Managing Director

Rachel  Bombara

Publishing with a Global Mindset: Do’s & Don’ts of Re-using Documents across eCTD Applications

Rachel Bombara

Certara, United States

Sr. Regulatory Services Manager

Priyanka  Kumari, DMD

Optimizing Product Label Management: Enhancing Compliance and Efficiency

Priyanka Kumari, DMD

Indegene, India

Senior Manager, Regulatory Affairs & Labeling

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