Senior Director, Regulatory Affairs Precision for Medicine Frederick, Maryland, United States
Description: One of the main challenges of bringing a companion diagnostic (CDx) to the European market is navigating the complexities of the combined study process under the IVDR. With the clinical performance study (CPS) application process being so decentralized, the nuances in the requirements of each member state and ethics committee can add significantly to the timelines of an already long drawn drug trial. Therefore, it is critical that both pharma and diagnostic partners work closely together to plan a successful outcome. This session will provide insights on best practices in joint collaboration and implementation from an industry perspective.
Learning Objectives:
Develop a seamless filing strategy aligned with the drug clinical trial application process
Understand the CPS application contents ensuring country specific nuances have been considered
Recognize the role of the key players in the application process and how they can work together to optimize the process through successful planning and implementation
