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Virtual

Mar 05, 2024 1:00 PM - Mar 07, 2024 5:30 PM

(Central Europe Standard Time)

Post-Market Surveillance and Clinical Evidence: Medical Devices and Combination Products Workshop

FULLY BOOKED! This virtual workshop will provide relevant information to set up a PMS system, to know its challenges and opportunities, and to show the interdependencies between PMS, risk analysis, and clinical evaluation.

Overview

The clinical evaluation of a medical device is updated throughout the lifecycle of a medical device with clinical data from Post-Market Surveillance (PMS) activities including Post-Market Clinical Follow-up (PMCF). Clinical evidence is needed to conduct a proper determination of the Benefit-Risk profile under normal conditions of the intended use of the device and to demonstrate acceptability of that profile based on current knowledge/state-of-the-art in the medical device field concerned.

Medical devices including Software as medical devices (SaMD) are also used in combination with a medicinal product leading to more innovative and complex products. Monitoring the safety and performance of medical device constituents is also important to ensure patient safety and minimize the risks associated with the use of medical devices.

This virtual workshop will provide relevant information to set up a PMS system, to know its challenges and opportunities, and to show the interdependencies between PMS, risk analysis, and clinical evaluation to continuously evaluate the safety and performance of a medical device and confirm the acceptability of the benefit-risk profile when used as a stand-alone device or as a constituent part of a drug-device combination product.

It will offer the experience from notified bodies, regulatory authorities and industry experts.

Featured topics

    • RMP - managing residual risks
    • Clinical data and sufficient clinical evidence
    • PMS system including PMCF
    • PMS and PMCF expectations
    • Clinical data and PRRC
    • PMS for a SaMD
    • AI
    • DDC products
    • Clinical evidence for drug-led DDC products
    • Regulatory perspective on PMS for MD and drug-led DDC
    • Industry perspective on PMS for DDC
    • PMS for connected combined products
    • Vigilance/PMS safety reporting for DDC
    • Adverse events in digital age
    • Challenges on DDC

Who should attend?

  • This workshop is intended for professionals working within the pharmaceutical industry in:

    • Post-Market Surveillance
    • Vigilance/Safety
    • Regulatory Affairs
    • Clinical Affairs
    • Digital Health

Learning objectives

  • At the end of this virtual workshop the attendants will be able to:

    • Outline the requirements of Post-Market Surveillance for medical devices and device constituents of Drug-Device Combination Products
    • Identify the relevant clinical data needed to confirm the acceptability of the benefit/risk profile of your product
    • Recognize the interdependencies and outputs loops within a PMS, clinical evaluation, and risk management process

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