OCRA-DG’s 30th Anniversary Annual Conference

NAMSA invites you to join us at OCRA-DG’s 30th Anniversary Annual Conference on August 2 in Huntington Beach, California. The conference features renowned speakers from the US FDA and EU Notified Body, as well as industry leaders and subject matter experts, many of whom are from the FDA.

NAMSA EDUCATIONAL SESSION

The Role of Real-World Evidence in Supporting Medical Device Regulatory Submission
Presented by Tyson Rogers, Principal Strategy Consultant, Biostatistics

Program Synopsis & Learning Objectives:
The last 10 years have seen rapid development in the availability and use of real-world data (RWD) for development of real-world evidence (RWE). The acceptance of real-world data for regulatory purposes depends on both the data being fit-for-purpose and the use of appropriate analysis methods to limit potential biases in the generation of evidence. As experience with RWD/RWE has matured, regulatory applications have expanded substantially. As a sign of that maturation, FDA’s CDRH released a draft update to the “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices” guidance document in December 2023. With ever-expanding options for both data sources and methods, it can be challenging to chart an efficient course toward FDA acceptance of RWE for your particular regulatory objective. This presentation will provide an overview of the current RWD/RWE landscape and highlight recent developments in available methods for translating real world data to real world evidence, with a focus on regulatory applications.

COMPLIMENTARY CONSULTATIONS
Please get in touch with us to reserve your complimentary 30-minute consultations with NAMSA’s MedTech expert throughout the event. We look forward to the opportunity to work with you. We hope to see you there!