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As regulatory teams build their plans for the year, the inaugural Medtech Regulatory Performance report provides some important benchmarks to consider in the areas of regulatory affairs team staffing, efficiency, and technological adoption. The new survey of 200 medtech regulatory professionals yielded some expected and some unexpected results, including a disconnect between perceived capabilities and actual performance for many regulatory teams. This interactive webinar will explore the study’s findings, regulatory predictions for 2023, and how regulatory affairs leaders can position themselves and their teams for success.
James Gianoutsos, Founder and CEO of Rimsys, joined by regulatory experts from PA Consulting, will provide data reactions and insights. They will discuss best practices for regulatory team setup and size, common regulatory activities, issues and compliance, and technology. And they will of course take questions.
At the conclusion of this webinar, participants should:
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.
Regulatory affairs pofessionals and quality leaders within the medtech community
James GianoutsosFounder and CEO, Rimsys
James Gianoutsos is the Founder & CEO of Rimsys Regulatory Management Software, a cloud-based solution to digitize, automate, and create regulatory order for MedTech companies. He is a quality assurance and regulatory affairs professional who has a diverse background in the medical device, pharmaceutical and biologics industries. Gianoutsos’ professional experience includes the design, premarket approval, clinical trials, manufacturing, distribution, and post-market surveillance of drug products and class I, II, and III medical devices. It also includes products in a variety of clinical applications including infant jaundice management, neonatal respiratory care, infant incubation, sleep therapy, management of respiratory insufficiency, surgical adhesive for internal use, surgical sealant for prevention of gastrointestinal leaks, and bone-healing accelerants. Gianoutsos has extensive experience in establishing and maintaining quality management systems in accordance with the FDA, ISO, cGMP, MDD, MDR, MDSAP, CMDCAS requirements and standards and has helped develop and submit multiple regulatory filings including premarket approvals, 510(k)s, design dossiers, technical files, and INDs. James holds a B.S. in operations management as well as an MBA with a concentration in operations management and strategy from the University of Pittsburgh.
Michael PeachVice President of Marketing, Rimsys
Michael Peach is the Vice President of Marketing for Rimsys, where he leads product marketing, demand generation, digital marketing, content, and branding for Rimsys’ regulatory management software. Prior to Rimsys, Peach led product marketing for several venture-backed software startups, including Tray.io, Lob, and Pendo, where he led messaging, positioning, launch, market research, and analyst relations.
Michael also worked across IBM in several marketing roles, leading product marketing and demand generation teams for their mobile, application integration, and business process management portfolios. He has extensive market research experience, working with IBM’s Institute of Business Value on executive and c-level studies and Mintel Comperemedia on consumer research. Peach holds a B.A. from Santa Clara University and an MBA from the University of North Carolina.
Marck AghnatiosMedical Device Expert, PA Consulting
At PA Consulting, Marck Aghnatios supports medtech clients to develop innovative products and accelerate revenue streams—from user need and business strategy, through prototyping and development, to manufacturing and launch to market, including incubation, prototyping and joint R&D. This also includes incorporating digital services to improve patient experience, measure outcomes, and develop new ways of engaging and contracting with the industry, whilst also finding new ways to relieve operational pressures, technology adoption and cost controls—across quality, regulatory, R&D, manufacturing, and the supply chain.
Rowan NiddRegulatory Affairs Expert, PA Consulting
Rowan is a Regulatory Affairs and Quality expert with extensive experience in bringing new products to market, through effective regulatory, quality, and labeling strategies, process design, and management. He has led multiple global regulatory and quality projects to improve productivity and speed to market for new drugs and medical devices.
Rowan has extensive experience in LIM and RIM systems and has led and supported the development and implementation of the necessary systems, tools, and processes to support drug and device development, focusing on optimization using high-quality, intelligent data.
Before joining PA Consulting, Rowan spent several years designing and implementing RIM systems, including quality, regulatory, process optimization, system integration and data quality and management.
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