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