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Session 8, Track 2: Global Submissions Without Borders: Harmonizing Processes, Data, and Technology Across Diverse Health Authorities
Session Chair(s)
Vladimir Penkrat, MBA
Associate Vice President – Regulatory Affairs, Indegene, United States
This session provides real world case study experiences in multimarket filing to achieve accelerated approvals through the process of harmonizing content, processes and responsibilities. Through effective planning and alignment of content across market filings the submissions can be optimized toward multi market readiness. The session will further deep dive into approaches where technology can enable a data centric model to further enable content harmonization through digital means as well as the use of Cloud Based Centralized Spaces for Health authorities to review filed applications.
Global Submissions Without Borders: Harmonizing Processes, Data, and Technology Across Diverse Health Authorities
Lucie Svobodova, Novavax
Smart Submission Publishing including Multi-Authority Collaboration
Schei Dattner, EXTEDO GmbH / cormeo GmbH
Accelerate Data Standard Compliance with an Enterprise Data Remediation Framework
Brooke Casselberry, Epista Life Sciences
Learning Objective :
- Apply a systematic approach to harmonizing global submission processes and content
- Build a scalable framework for managing regulatory information across markets with varying requirements
- Describe key data and process challenges in implementing data standards across global product portfolios
- Learn how cloud based regulatory spaces enable secure regulatory collaboration and data submission
Speaker(s)
Global Submissions Without Borders: Harmonizing Processes, Data, and Technology Across Diverse Health Authorities
Lucie Svobodova, PharmD
Independent Consultant, A-REG Solutions, Czech Republic
Smart Submission Publishing including Multi-Authority Collaboration
Schei Dattner, MBA
CPO & CSO, Germany
Accelerate Data Standard Compliance with an Enterprise Data Remediation Framework
Brooke Casselberry, MS, RAC
Vice President, Advisory and Delivery, Epista Life Science, United States
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