IVDR Impact on Clinical Trials Assays and Companion Diagnostic development 07.10.2025

Duration: 2 hours | 3:00 – 5:00 PM Central European Summer Time | 9:00 – 11:00 AM US Eastern Daylight Time
Date: October 7th 2025, Online
Speakers: Véronique Treil, Pharm D and Silvia Anghel, PhD

Training objectives: 
- Understand how to manage IVDR and CTR compliance of assays used in clinical trial studies in Europe
- Clarifies pharmaceutical sponsor and device manufacturer’s responsibilities for regulatory compliance to IVDR
- Identify IVDR requirements for Companion Diagnostics clinical evaluations and conformity assessment

Training content:
- Provide an overview of the 2017/746 EC Regulation (IVDR) and the qualification of assays as In Vitro Diagnostic devices (IVD) and specifically as Companion Diagnostics (CDx) devices.
- Define the impact of the full implementation of CTR (2014/536) on assays used in drug clinical trials and responsibilities of the different stakeholders in ensuring compliance
- Understand the different types of Clinical Trial Assays, and the key elements to ensure regulatory compliance to IVDR and CTR.
- Review the specific requirements for the conformity assessment of Companion Diagnostics under IVDR
- Define approaches for an efficient clinical evidence strategy for Companion Diagnostics

Training format: 
- Presentations with interactive discussions
- Group and individual exercises
- End of training assessment

Training certificate:
Participants will receive a certificate upon successful completion of the end of training assessment.

Who should attend:
- Executive management
- Assay development scientists and IVD product managers
- Pharmaceutical Clinical Affairs and Regulatory Affairs personnel in charge of developing a clinical strategy involving companion diagnostic, designing the clinical trial studies and ensuring regulatory compliance.
- IVD device manufacturer Clinical Affairs and Regulatory Affairs personnel in charge of developing a clinical strategy involving companion diagnostic, designing the clinical performance studies and ensuring regulatory compliance.

Price:
EUR 215 incl. course material and certificate