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This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
This is an On-demand
recording from July 2020.
Regulatory affairs professionals must have both a solid
foundation surrounding regulatory strategy and an in-depth understanding of how
this plan links to the overall product development strategy to achieve
efficient, cost-effective development outcomes and commercialization success.
Whether navigating a new regulatory pathway, understanding
how to secure clinical data to achieve successful commercial outcomes, or
ensuring reimbursement strategies are coordinated with regulatory strategy
throughout the planning process, it is essential all stakeholders to take steps
to secure broader market success for newly developed medical technologies.
This webcast will focus on best practices and proven
strategies to address challenges presented by today’s shifting regulatory
environment and how early integration of regulatory, reimbursement and clinical
research planning are the keys to commercial success.
Intermediate: Content is designed based upon the
assumption that individuals have basic knowledge of the topic(s) and/or
demonstrated competence related to the topic(s). Higher-level concepts are
introduced during lectures; exercises requiring synthesis and/or application of
concepts are incorporated into the activity.
Understand how looking beyond current regulatory
approaches can lead to commercial success
Review common challenges related to the
regulatory approach of “least resistance”
Reason why regulatory approval does not always
Apply best practices to achieve effective
clinical study design through early planning and integration of regulatory
affairs and reimbursement requirements
Explain how leveraging best practices and
tactics linking regulatory, reimbursement and clinical strategies is key to saving
time and costs throughout the development process and accelerating
Who Should Attend
Medical device industry executives
Regulatory affairs professionals
Clinical affairs professionals
Global strategy business managers
Regulatory affairs and operations leaders
Product managers and business analysts
Medical writing professionals
Risk management professionals
Edward Black, director of global reimbursement
Edward Black serves as NAMSA’s Director of Global
Reimbursement Strategy where he oversees reimbursement strategy, payer
relations and health economics for medtech and biotech companies in the U.S.
and abroad. Prior to joining NAMSA, he founded Reimbursement Strategies, LLC in
2008, a medtech consultancy focused on reimbursement services. In total, Mr.
Black possesses 25 years of experience in health and provider network
management within U.S. healthcare systems. He has served on two national
advisory boards where he was responsible for leading efforts for consistency in
medical benefit and payment policies. Mr. Black is active in several global
medical technology initiatives and is a frequent international lecturer. He
serves as an adjunct faculty member of the University of Minnesota—Minneapolis
in the Masters of Science in Medical Device Innovation Program, and is a
Reimbursement Advisor at the U of MN Office for Technology and at the National
University of Ireland Galway (BioExel Program).
Mr. Black earned his MBA at Minnesota State
Vincent Legay, director of global product
development strategy, NAMSA
Vincent Legay possesses over 15 years of experience in the
medical device industry and currently serves as NAMSA’s Global Director of
Product Development Strategy. In his role, he leads a team of senior
consultants specialized in product development consulting, regulatory, clinical
and preclinical strategies that provide solutions across the entire medical
device lifecycle continuum. His expertise also includes management of
sterilization, biocompatibility, clinical evaluation, risk management and
quality management systems for medical device Sponsors throughout the globe.
Mr. Legay holds a PhD in Biology from Lyon University (France) and an executive
MBA from EMLyon (France).
Carla Wiese, sr. product development
Carla Wiese currently serves as NAMSA’s Sr. Product
Development Strategist where she provides strategic consultation to clients in
the medical device industry to help them meet commercialization goals. Carla
also acts as a Program Director leading client projects from early stage device
development through commercialization; ensuring that the client has key
resources, managing project tasks/timeline and contributing to budget
development. Prior to NAMSA, she gained regulatory expertise while serving at
the U.S. Food and Drug Administration (FDA) as a Lead Reviewer and Engineering
Consultant in the Division of Cardiovascular Devices. Carla also led the Early
Feasibility Studies Program at FDA working across CDRH divisions and in
collaboration with the National Institute of Health (NIH) and the Centers for
Medicare & Medicaid Services (CMS) to pave a clearer pathways for clinical
evaluation of novel technology in the US. Additionally, Ms. Wiese’s experience
includes research and development, serving as an engineer in the medical device
industry for over a decade for both large and small organizations. Ms. Wiese
holds a BS in Mechanical Engineering from The Ohio State University.