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Session 5, Track 1: Enhancing Data Reliability and Acceptability of RWD to support Harmonized Regulatory Decision Making Across US, China and EU
Session Chair(s)
Jillian E. Carinci, MS
Senior Director, Head of Submission Sciences
Biogen, United States
The definition of data sources from the US FDA, EU and China will be surveyed for specific descriptions. Provide a market consultation and global road map (focusing on China, US, and European Union) and literature survey for the future of Regulatory Decision Making using RWD, proposing solutions for consistency of decision making across regions. AI as an enabler of data reliability will be explored. References to AI (predictive/ generative) will be contextualized to support the data referenced. AI is usable in a defined context. AI approaches assume data is reliable. Data can be reliable only if it is appropriately structured. AI can help with data standardization. [We will explain the roles that AI plays in generating data standards). Different stages of a product lifecycle will be studied in terms of expanding indications, geographies, and requirements of HTAS and payers. The findings for this paper will be a good reference point for Regulators, HTAs and industry members.
EU Focus
David Sidney Ross, AstraZeneca
Real-World Data (RWD) in Regulatory Submissions in the US: Challenges and Solutions
Brian Gillette, Droice Labs
China Focus
Tong Guo, GoBroad Healthcare Group
Learning Objective :
At the conclusion of this session, participants should be able to:
- Define how to improve consistency between FDA, EMA, and China
- Identify global use cases for regulatory collaboration (e.g., multinational and non-interventional study data)
- Acknowledge RWD will be used regionally and is unlikely to be shared globally
Speaker(s)
EU Focus
David Ross, MBA, MSC, PMP, RAC
AstraZeneca, United States
Senior Director, Digitial Advocacy and Policy
Real-World Data (RWD) in Regulatory Submissions in the US: Challenges and Solutions
Brian Gillette, PHD
Droice Labs, United States
VP, Data
China Focus
Tong Guo, PHD
GoBroad Healthcare Group, China
Strategic Advisor
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