Under the MDR, PMCF activities will be mandated as part of medical device surveillance programs. These activities should ultimately ensure patient safety through continuous monitoring of certain medical devices. However, with the MDR scheduled to go into full effect on May 26, 2020, manufacturers are scrambling to prepare for MDR compliance. While conducting PMCF activities may appear costly and burdensome, this process can be streamlined and even automated through technology.
During this webinar, we will present a step-by-step approach to defining a successful PMCF plan and discuss different PMCF scenarios and design types. Featuring Derk Arts, MD, PhD, Founder and CEO of Castor, and Nadine Leistner, PhD, Chief Scientific Officer of MEC-ABC Medical Care and Product Development.
We will illustrate the steps needed to put together a PMCF plan that will pass Notified Body scrutiny. We will also show how you can put technology to work to support you with a wide array of PMCF approaches. Specifically, we will discuss the following topics:
- Analysis of existing clinical data (clinical evaluation and instruction for use)
- Performing claim analysis and PMCF parameter deduction
- Justification of parameter, sample size and selection bias
- Selecting a PMCF approach and enrollment strategy
- Selecting a platform that suits the approach
- Q&A session with our panel to get answers to your most pressing questions about PMCF
Derk Arts, MD, PhD, Founder & CEO of Castor EDC, Epidemiologist
Dr. Derk Arts has over 10 years of experience in medicine, research, and data management. He received his MD from Vrije University in 2011 and his Ph.D. from the University of Amsterdam in 2016. During his MD training, Dr. Arts identified a major problem in medical research. Due to the unavailability of affordable, user-friendly data capture tools, researchers were deviating to non-compliant alternatives that reduce data quality, security, and reusability, and greatly increase research data waste.
To solve these issues he founded Castor, a global healthtech company that enables manufacturers and research organizations to optimize clinical trials through the capture of high-quality clinical data that are reusable, thus maximizing their impact.
Since 2012, Castor has delivered solutions to support over 4,000 studies in collaboration with medical device, biotech, contract research, and academic organizations.
Nadine Leistner, PhD, Chief Scientific Officer of MEC-ABC, Biologist
Dr. Nadine Leistner has over 9 years of experience in preclinical and clinical research. She received her PhD from RWTH Aachen University in 2015. Dr. Leistner had the idea of creating a platform to bring the medical device industry and physicians closer together in order to preserve innovation under the new MDR and strengthen diversity on the market. During the company’s journey she identified the pillars for the bridge that is needed between medical device industry and clinical research. One of her greatest strength is to fill the manyfold gaps between regulatory needs and clinical routine with apt solutions. As Chief Scientific Officer she has led a team of five consultants/ medical writers in the field of clinical affairs for medical devices for three years.
Who Should Attend?
This webinar may be of interest to senior professionals within the medical device industry in the areas of:
- Clinical / Medical Affairs
- Clinical Research / Operations
- Regulatory Affairs / Compliance
- Clinical Data Management
- Medical Device Manufacturing
- Contract Research Organizations
- Research and Development
- Product Management
What You Will Learn
Webinar attendees will learn about:
- Strategies to optimize PMCFs
- Different approaches to PMCF design
- PMCF enrollment strategies
- PMCF data extraction
- Expert opinions and insights on PMCF from a live Q&A
A global healthtech company, Castor enables manufacturers and research organizations to optimize clinical trials through the capture of high-quality clinical data that are reusable, thus maximizing their impact. Since 2012, Castor has delivered solutions to support over 4,000 studies in collaboration with medical device, biotech and academic organizations. Castor’s capabilities include Electronic Data Capture (EDC) to maximize productivity in clinical studies and integrate data from multiple sources, such as clinicians, patients, devices, wearables, and EHR systems; electronic Patient Reported Outcome (ePRO) forms to administer surveys and collect clinical data into a centralized platform; eConsent to facilitate and automate patient enrollment processes; and many more cost-effective, custom solutions.
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