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Session 11 Track 2: Optimizing Submission Filings: Understanding the Challenges and Developing Strategies Accelerating Submission Delivery to Health Authorities
Session Chair(s)
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
Speaker(s)
A Multi-faceted Approach to Achieving Faster Filings
Patterson Shafer
FTI Consulting, Inc., United States
Managing Director
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
Optimizing Product Label Management: Enhancing Compliance and Efficiency
Priyanka Kumari, DMD
Indegene, India
Senior Manager, Regulatory Affairs & Labeling