概览
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
项目委员会
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Anna Amich, MSc Director, Patient Safety Device & Digital
AstraZeneca, Spain
