Sponsored by:
Complimentary Webinar
May 24, 2022 | 11:00 a.m. - 12:00 p.m. ET
Literature Reviews Strategies for
Post-Market Surveillance -
A Best Practices Webinar
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Learning Objectives:
- Understanding the relationship between risk, post-market surveillance requirements, and performance evaluation.
- Transparency and compliance for literature reviews in the post-market surveillance context.
- Employing automation and smart workflows to effectively monitor clinical literature and databases.
- Implementing best practices for literature reviews supporting a post-market surveillance quality management system.
- Considering operational efficiencies to streamline data gathering and analysis.
Post-market surveillance (PMS) is a requirement for medical device manufacturers and a critical element of EU MDR. The regulation calls for manufacturers to demonstrate that they have performed a robust justification to launch a device and keep it on the market. PMS aims to provide feedback on the benefit-risk determination, clinical evaluation, usability, safety and clinical performance as well as reportable trends, and technical documentation. Much of this insight and data can be sourced through scientific literature.
But how does one develop a robust surveillance program supported by unprecedented volumes of research and ever evolving grey literature?
In this webinar roundtable, DistillerSR customer Sara Garbin from the Sleep and Respiratory Care Unit (SRC) at Philips and Bassil Akra from Akra Team GmbH, reflect on challenges and opportunities for medical device companies conducting post-market surveillance as part of their compliance path.
SPEAKERS
Dr. Bassil Akra
Founder & CEO
AKRA Team GmbH
Dr. Bassil Akra is founder and CEO of AKRA Team GmbH. He spent the last decade as a subject matter expert in the biggest notified body in Europe and represented locally and globally the notified body association in various European roundtables. Dr. Akra played an essential role in the implementation of EU-MDR (MDR 2017/745) and was involved in the drafting of several European guidance documents. He is a regular speaker in the medical devices industry and a recognized authority in EU-MDR compliance.
Sara Garbin
Sr. Clinical Development Scientist
Philips
Sara has spent the past 3 years in a clinical role at Philips, working with medical devices for sleep and respiratory care. As a Senior Clinical Development Scientist, Sara develops and executes strategies for the collection and dissemination of clinical evidence. Much of her work has focused on EU MDR evaluations. Sara has spent the past 9 years working in clinical research, including 6 years in pharmaceutical research. She holds a Bachelor of Science from the University of Pittsburgh.
Lee-Anne Bourke
Account Executive
DistillerSR
Lee-Anne is a librarian with a keen interest in bibliometric trends, literature review methodologies and information management. She joined Evidence Partners in 2021 as an Account Executive. She is passionate about research and is a published author of Cochrane, Campbell and JBI systematic reviews.
Christa Goode
Medical Writing Director, Worldwide Medical Operations
Johnson & Johnson Medical Devices
Christa is a Director in the Clinical and Medical Affairs department who oversees 100+ Medical Writing Managers, Writers, Information Specialists, Librarians, and Programmers for Johnson & Johnson across all Medical Devices companies supporting both US FDA and EU MDR Post-Market Surveillance requirements and activities (CERs, PSURs, SSCPs, PMCFs ,IDEs, PMAs) for a wide scope of therapeutic areas including cardiovascular, GI, cell therapy, women’s health, general surgery, and orthopedics. Her team owns published literature and associated software tools for systematic reviews and meta-analyses. She comes with 20 years in multiple leadership roles as an epidemiologist, clinical researcher, biostatistician and data manager with expert knowledge in research protocols, data collection instruments, database design, analytic plans, clinical summaries, and biostatistics. She also led the SME during EU MDR audits on PMS requirements specifically around systematic review methodologies to justify the safety and performance of medical devices. She has developed a global training program for medical writers and other multifunctional teams across the medical device sector on clinical evaluations and systematic literature reviews.
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