Post Market Clinical Follow-up in Action: A Practical Approach to EU MDR Compliance
About
Date/Time
Date(s) - June 20, 202410:00 AM - 11:00 AM CT
This comprehensive webinar explores the multifaceted aspects of Post-Market Clinical Follow-up (PMCF) under the EU’s Medical Device Regulation (MDR). We’ll delve into the expectations of PMCF, strategy development and evidence gathering. We’ll also provide practical examples, consider the transferability of clinical data between regions, examine country variability within the EU and provide insights into budgetary considerations for PMCF.
Key Learning Objectives:
- Understanding PMCF Background and Strategy
- Learn about the context of PMCF
- Develop your strategy
- Understand options to generate clinical evidence
- Practical Examples and Regional Differences
- Gain insights from practical examples
- Developing high-quality vs low-quality surveys
- Implementation of both EU and rest of world PMCF activities to meet EU MDR requirements
- Gain insights from practical examples
- Data Transferability and Budgetary Considerations
- Understand the considerations for transferring clinical data between regions
- Variability of PMCF requirements within the EU
- Get a sense of the time and cost implications of completing a PMCF study
Whether you’re a medical device manufacturer, a regulatory affairs professional, or a quality assurance specialist, this webinar will equip you with the knowledge and tools to gather the right evidence for PMCF under EU MDR.
Don’t miss this opportunity to learn from industry experts and network with peers facing similar challenges. Register today!
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Speaker
Adrian Keene, BSc (Hons)
Associate Vice President of Global Biological Safety & Validation and EMEA Consulting ServicesAdrian has more than 30 years of experience in product development and registration within the medical device industry, with manufacturer, regulatory agency, and consultancy perspectives. Adrian’s knowledge of new product development combined with EU regulatory requirements enables him to provide a balanced and pragmatic interpretation of the needs and expectations of both regulators and manufacturers. Before working at NAMSA, Adrian was Head of Notified Body for the UK Notified Body SGS and spent 10 years in the Notified Body sector, where he was responsible for conformity assessment activities of high-risk (class III) devices under the Medical Device Directive (MDD).
He is a toxicologist by training and worked for several years in the Research and Development (R&D) sector of the medical device industry, providing toxicological and risk management strategies to expedite product launches for multiple global registrations.
Sara Finocchietti
Senior Strategy Consultant, ClinicalSara Finocchietti has over 15 years of experience in the medical device industry with a wide range of therapeutic areas. Her core focus has been on orthopedics, neurovascular and neuroscience. Her career started in academia developing innovative medical devices and providing clinical and regulatory strategy. Her previous experiences include working as a Clinical Affairs Manager at a French manufacturer with a full orthopedic portfolio, defining the strategy to transition to the EU’s Medical Device Regulation (MDR).
Sara holds an MSc in Biomedical Engineering from the University of Genoa (Italy) and a PhD in Clinical Science from Aalborg University (Denmark).
Christophe Van der Linden
Executive Director Marketing Insights & ConsultingChristophe has been in the industry for over 30 years, focusing on medical devices specifically in these therapeutic areas: (interventional) cardiology, imaging and IVD.
As the Executive Director and founder of SUAZIO, he has helped guide global companies over the past three decades through various initiatives and challenges in the life science market. His competencies span a variety of topics, including New Product Introduction, Pricing and Customer Experience (NPS). In recent years he has also conducted real-world evidence and PMCF studies.
Jasper van de Sande
Senior Business ConsultantJasper has been in the industry for over 20 years, with 15 years focused on medical devices specifically in orthopedics, cardiovascular and neurology. Jasper previously led market insights and new business development analytics at Johnson&Johnson, Medtronic and two small startups. In his market insight roles, Jasper explored numerous market opportunity assessments, gap analyses, concept testing, pricing studies and M&A assessments. In recent years he has also conducted real-world evidence and PMCF studies. He holds a master’s degree in Economic Psychology and a bachelor’s degree in Physiotherapy.