Meeting Regulatory Clearance & Market Access Goals through Innovative Design of Medical Device Clinical Studies, Risk-Based Monitoring of Investigational & Post-Market Research, Streamlined Approaches to Site Selection and Rapid Patient Enrollment Opportunities
ABOUT THE CONFERENCE
As healthcare policy has continued to evolve towards a heightened level of cost-effectiveness, medical device corporations are being asked to provide comprehensive clinical data to support not only regulatory clearance, but to also support market access through detailed cost-effectiveness measurement data generated from extensive clinical research. This additional data burden requires clinical research teams to redesign clinical studies in an innovative manner to ensure data collected will support economic markers in addition to traditional safety and effectiveness measures. The use of risk-based monitoring, rapid enrollment strategies, as well as a firm understanding of regulatory and market access requirements is essential to ensuring the long-term growth of the industry through new product introductions which will continue to revolutionize the delivery of care.
The 9th Annual Innovations in Medical Device Clinical Research conference will provide participants with a unique, high-level opportunity to discuss the challenges as well as opportunities that exist within medical device research, with a focus on innovation and patient engagement. International considerations will also be addressed, with presentations focused on the new EU Medical Device Regulation’s impact on clinical research alongside new Chinese regulations which remain unclear and require interpretation. Throughout, presenters will share deep insights into how leading corporations are addressing the ongoing challenge of providing high level, gold-standard clinical data within the timelines and budgets initiated by corporate leadership.
500 N. Dearborn Suite 500 | Chicago, IL 60654
Chicago, IL 60654