Getting to Yes from Regulators to Payers and Beyond - the Decision-Maker Gauntlet
After Yes - Navigating the Rules of the Road in Today's Marketplace
Regulatory, Quality and Good Manufacturing Practices
The demand for Real World Evidence (RWE) has increased dramatically, with the payers requiring more evidence to make their decisions and the global regulatory bodies looking to real world data for pre- and post-market decisions. Savvy MedTech companies are using real world data sets to their competitive advantage. Historically a practice for disruptive products, today, RWE could be a critical component of successful go to market strategy. This session will look at how to make the collection of this data more efficient, accessible, and compliant. In a panel moderated by Seth Goldenberg, VP of Medical Device and Diagnostics for Veeva, the audience will hear the perspectives from Owen Faris, Clinical Trials Director - CDRH at US Food and Drug Administration, Rachel Rath, NESTcc Deputy Director and Manish Bharara, Regulatory and Clinical Affairs, Siemens Healthineers, on the collection, application and challenges of RWE, ultimately resulting in better outcomes and safer and more efficient use of technology.