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HBA Orange County presents

HBAOC & IQVIA: Use of Real World Evidence in Clinical Development to Enhance Regulatory Submission


Date and time
Tuesday, 01 December
09:00AM - 10:00AM PST
Location
Virtual Zoom

Event Contact
Karen Jimenea
9095381978
Competencies
3. Exhibits business and industry acumen

More pharmaceutical companies are working to understand how real world evidence (RWE) can strengthen their submission packages and identifying opportunities to do this across their portfolios. Pragmatic trials that combine the benefits of randomized controlled trials and real-world research are emerging to produce evidence that is fit for regulatory purposes and more. Innovative long-term follow-up methods drive efficiencies, particularly for gene therapies. External comparators provide context for clinical trials including submissions of single-arm trials. Regulatory agencies have signaled increased receptivity to the use of real world evidence (RWE) in regulatory submission in both the U.S. and global markets.

Join Nathalie Horowicz-Mehler, Senior Principal and Practice Lead of the Real World Evidence (RWE) team at IQVIA as she shares how RWE can be utilized to enhance regulatory submissions. With this session, Natalie offers three key takeaways:
• Improved understanding of global receptivity to RWE in Regulatory Submission including FDA, EMA, and Japan
• Understand how to identify an opportunity for RWE to inform submission package for your product or portfolio
• Use cases of real-world evidence in Regulatory Submission for effectiveness, especially for label expansions

Agenda 
9:00 - 9:10 AM Program Kick-off & Introductions
9:10 - 9:50 AM Session Proper
9:50 - 10:00 AM Q&A/Wrap-up

Registration information
Event is open to: HBA Members and Nonmembers
Online registration deadline: 1 December


Registration information

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 Price LevelRegular
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Registration: Regular Registration

 Member$10.00
 Member - Euro€9.00
 Non-Member$15.00
 Non-Member - Euro€13.00

By registering for this event, you acknowledge that you may be photographed, videotaped and/or audio-taped during the course of the meeting and hereby give permission for your image, voice, or survey comments to be used in education, training, promotion and/or trade and communications media by the Healthcare Businesswomen's Association in any and all media throughout the world, without restriction as to frequency or duration of usage.