Mastering Clinical Performance Studies under IVDR

FROM STRATEGY TO DELIVERY

Are you prepared to tackle the challenges of clinical performance studies under the IVDR?

On demand

1h

In Vitro Diagnostics

English

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This webinar will delve into the strategic, regulatory, and operational aspects of conducting successful clinical performance studies.

With input from IVD experts, we’ll explore what it takes to create a robust and compliant study design, effectively source samples and sites, and meet the unique challenges posed by self-testing and near-patient testing devices. Additionally, our panel will discuss the requirements outlined in Annex XIV of the IVDR and provide tips on managing performance study applications across EU Member States.

Whether you’re preparing for a new submission or looking to refine your current approach, this session is designed to provide actionable guidance to help you succeed.

Speakers

QbD_IVD_qarad-1

Annelies Rotthier

Annelies Rottheir

Scientific Affairs and IVD Clinical Evidence Manager

Annelies Rotthier is a senior IVD consultant. After her Ph.D. in Molecular Genetics at the VIB Institute in Antwerp, she pursued her career in the field of molecular genetics as R&D manager in the spin-off company Multiplicom and later as Director Product Development at Agilent Technologies, a major player in Next Generation Sequencing IVD applications.

She brings her experience to support companies with product development in compliance with IVD Regulation and with the transition to the new IVD Regulation. Risk management activities in accordance with ISO14971 is one of her main expertise.

Kirsten Van Garsse-3

Kirsten Van Garsse

Director Representative Service & Mangager IVD - Regulatory Affairs

Kirsten Van Garsse obtained her Master’s degree in Biomedical Sciences in 2002 from the Vrije Universiteit Brussel (VUB) and has amassed extensive experience in the In Vitro Diagnostic Medical Device Industry. She joined Qarad, now part of the QbD Group, a consulting company specialized in Regulatory Affairs and Quality Systems for the IVD and Medical Device industry, at the end of 2017.

In her role as Director of Authorized Representative Services & Manager of IVD Regulatory Affairs, Kirsten applies her wealth of experience to Regulatory Affairs projects, adeptly translating regulations into compliant business processes and applications. Additionally, she oversees the various Representation Services offered by Qarad, ensuring clients receive expert support in navigating regulatory requirements.