Post-market clinical follow-up (PMCF) studies are necessary for continuously monitoring the clinical benefits, performance and safety of a medical device once it is released on the market. As part of a broader post-market surveillance (PMS) strategy, these studies are crucial for assessing the long-term behavior of the device and ensuring that the risk–benefit profile remains favorable when the device is used as intended.
In addition to satisfying regulatory requirements under the EU Medical Device Regulation (MDR), these studies may even support opportunities to expand both markets and labeling and allow the collection of real-world evidence to inform reimbursement programs.
While the specific requirements for PMCF activities may vary based on the type of device, its intended use and the associated risk, clinical investigations are the most robust activity for assessing the ongoing performance and safety of a device. Developing a comprehensive PMCF plan as part of a PMS strategy early in the device lifecycle helps ensure efficient design and implementation of these investigations to maximize study outcomes and address multi-stakeholder requests.
Register for this webinar to explore key regulatory and clinical considerations for PCMF investigations under EU MDR.
Speakers
Frank Keulen, Director, Program Delivery, MedTech, Premier Research
Frank Keulen, Director, Program Delivery, MedTech, is responsible for overseeing key device programs ensuring successful management and coordination of efforts assigned to all members of the global project team to support milestone achievement and overall project delivery. Frank line manages the EU project management team (PM level).
Frank has over 13 years of experience in medical device clinical research, including project management and line management, overseeing the different phases of clinical investigations throughout the device life cycle. He has worked as Project Manager for two other CROs prior to joining the Premier Research team.
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Frank obtained a Master’s degree (MSc) in Physical Activity and Health, Specialization: Biology of Human Performance and Health at Maastricht University in Maastricht, Netherlands, and also holds a Bachelor’s degree in Medical Technologies at the Higher Technical School Zuyd in Heerlen, Netherlands.
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Caroline Perez, Associate Director, Regulatory Affairs, Medical Devices, Premier Research
Caroline Perez has more than 20 years of international clinical research experience in medical devices and pharmaceutical products. As Associate Director of Regulatory Affairs, she oversees critical elements of regulatory strategy and business acquisition, advising customers and members of the company’s clinical team on regulatory and technical subjects.
Prior to joining Premier Research in 2009 as a Senior Project Manager, Dr. Perez was a Project Manager and Clinical Research Associate at MedPass International, a Paris-based contract research organization specializing in medical devices. She also worked as a Clinical Research Associate at Ciba VISION, a producer of contact lenses, and at Bristol Myers Squibb. Her broad therapeutic experience spans medical devices, ophthalmology, oncology and neurology.
Dr. Perez holds a PhD in Organic Chemistry from the Institute for the Chemistry of Natural Substances in Gif-sur-Yvette, France, and did her post-doctorate study in Organic Chemistry at the Martin Luther University of Halle–Wittenberg in Germany.
Message PresenterWho Should Attend?
This webinar will benefit Managers and above at MedTech, biotech and specialty pharma companies with job functions including, but not limited, to:
- Clinical operations
- Medical affairs
- Project management
- Regulatory affairs
What You Will Learn
Attendees will learn about:
- The regulatory framework for PMCF
- Planning a PMCF strategy
- Designing a PMCF investigation
- Conducting a successful PMCF investigation
Xtalks Partner
Premier Research
Premier Research, a clinical research company, is dedicated to helping biotech, specialty pharma, and device innovators transform life-changing ideas and breakthrough science into new medical treatments. As a global company, Premier specializes in the use of innovative technologies for smart study design and trial management to deliver clean, conclusive data to sponsors. Whether it’s developing product lifecycle strategies, reducing clinical development cycle times, securing access to patients, navigating global regulations, maximizing the impact of limited rare disease data, or providing expertise in specific therapeutic areas, Premier is committed to helping its customers answer the unmet needs of patients across a broad range of medical conditions. Visit premier-research.com.
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