Overview

Post-Market Surveillance (PMS) activities including Post-Market Clinical Follow-up (PMCF) are conducted throughout the lifecycle of a medical device. These require compiling data from multiple sources, including sufficient clinical evidence to conduct a proper determination of the benefit-risk profile and to demonstrate acceptability of that profile based on current knowledge/state-of-the-art in the medical device field concerned.

This virtual workshop specifically addresses devices used with drugs or biologics and that serve to support or deliver these medicinal products effectively.

You will learn how to set up a PMS system, understand it’s challenges and opportunities, and see the interdependencies between PMS, clinical evidence, and risk management. This workshop will help you to know how 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 (DDC) product.

It will offer experience from notified body and industry experts.

Featured topics

- PMS for Medical Devices and Drug-Device Combination Products
- Risk Management: Interfaces with PMS and PMCF
- Clinical Evaluation and its Role in PMS - NB perspective
- Case Study on Risk Management and PMS
- Deep Dive into the EU MDR PMS and PMCF - NB perspective
- PMS for a Specific Device
- Benefit-Risk Assessment for Medical Devices
- PMS for a Connected Drug-Device Combination Product
- Case Study on Developing a EU MDR PMS Plan for a DDC Product
- Post-Market Device Safety Reporting for DDC Products
- Demonstrating Annex I Requirements for Single Integral DDC through PMS and Clinical Evidence - NB perspective
- PMS for Drug-Led Single Integral CP - Industry perspective
- Adverse Events in Digital Age
- Case Study on US FDA PMSR and EU MDR PMS for a Drug-Led Connected DDC

Who should attend?

This workshop is intended for professionals working within the pharmaceutical industry in:
- Post-Market Surveillance
- Pharmacovigilance
- Vigilance/Device Safety
- Regulatory Affairs
- Clinical Affairs
- Digital Health

Learning objectives

At the end of this virtual workshop participants will be able to:
- Follow the requirements of PMS for medical devices and device constituents of DDC products
- Identify the relevant clinical data needed to confirm the acceptability of the benefit-risk profile of your medical device
- Recognize the interdependencies and outputs loops within a PMS, clinical evidence, and risk management process

Program Committee

Anna Amich, MSc Director, Patient Safety Device & Digital
AstraZeneca, Spain

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