Panel Discussion: Defining a Unified Path Towards IVDR Compliance for Streamlined Approvals

• How has IVDR changed expectations for evidence generation, documentation, and timelines across regulators, notified bodies, pharma, and diagnostic developers?
• Is there any strategy change in aligning with notified bodies and regulators?
• What are the most common bottlenecks companies encounter during co-development; from clinical trials to MAA and conformity assessment?

Speakers:

Jörg Engelbergs

Scientific-Regulatory Assessor Targeted & Personalized Biomedicines

Paul-Ehrlich-Institut, National Competent Authority for Medicinal Products & CDx Devices

Rolf Thermann

Section manager

TUV Rheinland

Jai Pandey

Head, Global Device Regulatory for IVDs & Digital Health

Sanofi

Hilke Zander

Clinical Assessor

Paul-Ehrlich-Institut, National Competent Authority for Medicinal Products & CDx Devices

Renuka Pandya

Associate Director, Business Development

Foundation Medicine