Practical Considerations for Clinical Performance Studies under IVDR Presenter: Margot Borgel, PhD – Director, IVD Global Regulatory Affairs, RQM+
Clinical Performance Studies are required for certification of new IVDs to the market in Europe. The requirements for these studies were not previously in place under the directives and present new challenges for IVD Manufacturers looking to introduce novel devices to the European market.
This session will look at the requirements of Clinical Performance Studies as outlined in the IVDR and provide insights into practical implementation of the requirements for your device. The session will explore the logistics of clinical performance studies for devices under IVDR. Attendees will leave the session better poised to create the necessary documentation for clinical performance studies and to generate well designed studies for their IVDs under IVDR.
Companion Diagnostic Clinical Performance Studies under IVDR Presenter: Maham Ansari, MS, RAC – Senior Director, IVD Regulatory Affairs, Precision for Medicine
The clinical performance of a companion diagnostic (CDx) needs to be supported by clinical evidence, and this clinical evidence is often tied with a clinical study supporting the use of the CDx with a medicinal product. In the absence of EUDAMED, country specific authorization or notification of EU member states has become necessary. The Clinical Performance Study (CPS) application process can be complex and time consuming and can add to the timelines of an already long-drawn drug trial. This session will discuss the challenges and requirements of the CPS application process for CDx under the interventional clinical performance study requirements described in Annex XIV of the IVDR and provide insights on how this process can be optimized through effective planning and implementation.
Learning Objectives:
Upon completion, participants will be able to describe the requirements for Clinical Performance Studies according to the IVDR.
Upon completion, participants will be able to prepare clinical performance study plans and reports.
Upon completion, participants will be able to describe practical considerations and logistics in designing clinical performance studies.
Develop a seamless filing strategy by understanding the specific CPS Application contents while focusing on country specific nuances and timelines
Learn how to effectively work with the key players in the filing process such as Competent Authorities, Legal Representative, Pharma and Diagnostic manufacturer
Understand key considerations for CDx studies and develop an optimal path toward success
