Overview

Post-Market Surveillance (PMS) activities, including generation of clinical evidence, are essential activities conducted throughout the lifecycle of medical devices and drug-device combination (DDC) products. These activities require collecting and analyzing data from multiple sources to evaluate device safety and performance in real-world conditions.

This virtual workshop specifically addresses devices used with drugs or biologics and that serve to support or deliver these medicinal products effectively. For such devices, maintaining robust PMS is also important to demonstrate the ongoing safety and performance, confirm that the benefit-risk remains acceptable based on current available knowledge, meet regulatory requirements under the EU MDR and other frameworks, and protect patient safety while ensuring product performance.

Over three days, this virtual workshop will equip you with practical knowledge to establish and maintain an effective PMS system for medical devices and DDC products. Through presentations from Notified Body and Industry experts, real-world case studies, and interactive discussions, you will learn how to navigate the interdependencies between PMS, clinical evidence and risk management processes with particular focus on DDC products.

Participant Testimonials

Anna was an excellent host and demonstrated outstanding soft skills, creating a welcoming and engaging environment... I really enjoyed the session and appreciated the opportunity to learn from true experts. The content was insightful and valuable. Overall, a great learning experience! - Dr. Ioulia Alekxandrova - Head Drug Safety and Pharmacovigilance - Aspeya Switzerland SA

Featured topics

- Introduction, Overview and Objectives of MDR
- PMS Overview for MDs and DDCPs and Interfaces
- Introduction to Risk Management: Interfaces with PMS and PMCF
- Introduction to Clinical Data and sufficient Clinical Evidence - NB Perspective
- Case Study on Risk Management and PMS in Action
- PMS, PMCF and Evidence Overtime - NB Perspective
- Demonstrating Annex I Requirements for Single Integral DDC Through PMS and Clinical Evidence - NB Perspective
- PMS for a Specific Device/LI>
- PMS for Connected DDCP
- Case Study on Developing a EU MDR PMS Plan for a DDCP
- Complaint Handling for CPs in a Pharma Industry
- Adverse Events in Digital Age
- Post-Market Device Safty Reporting for DDCPs
- Device PMS for CPs Practical Strategies for Successful Implementation
- Case Study on US FDA PMSR and EU MDR PMS for a Drug-Led Connected DDCP

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
- Quality Assurance

Learning objectives

At the end of this virtual workshop participants will be able to:
- Apply PMS requirements for medical devices and device constituents of DDC products in accordance with EU MDR and relevant regulatory frameworks
- Recognize the interdependencies and outputs loops within a PMS, clinical evidence, and risk management process
- Implement effective safety reporting systems for device constituents while understanding the interface between device vigilance and pharmacovigilance
- Address challenges associated with connected DDC products in PMS activities

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