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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.
Demonstration of equivalence to a device already on the market is used in both the US and the EU medical device regulatory systems as supporting evidence for market access. The two systems have however rather different approaches in the scope and purpose of the regulatory pathway that the use of equivalence is supporting. This workshop will address the EU and the US use of equivalence, showing best practices, pitfalls and strategies based on practical examples and hands-on exercises.
In Europe, equivalence can used to provide supporting clinical safety and performance data for the clinical evaluation process of a medical device. This option has been available since the introduction of the medical device directives in the early 90’s. With time, its applicability has been refined and progressively limited. Today, the MDR provides a framework where clinical evaluation can be supported by data from one equivalent device with quite clear criteria for technical, biological and clinical characteristics. The EU session of the workshop will explore how the equivalence criteria in the MDR can impact regulatory and clinical strategies in new product development projects and significant changes to existing products.
The US approach to equivalence is quite different and not limited to the clinical aspects. Demonstrating substantial equivalence to a marketed device is a mandatory exercise for all premarket notifications (i.e. 510(k) submissions) and include both non-clinical and clinical performance data. Over time the concept of substantial equivalence has been refined and better specified in guidance documents. During the US session of the workshop, participants will learn how to select an appropriate predicate device, the relevance of the intended use and what data is expected in support of the demonstration of equivalence.
€ 975 Member | € 1,155 Nonmember
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Germany VAT number: DE329690496
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21 February 2022 (9:00am–5:00pm)
Equivalence in Europe:
22 February (9:00am-5:00pm)
Equivalence in US:
Andrea Sparti, PhDDirector Regulatory Affairs, Ypsomed AG
Andrea Sparti, PhD is Director of Regulatory Affairs at Ypsomed AG, a Swiss company, active in the field of drug delivery systems and diabetes care. Following his doctoral degree in biology, Andrea worked in biomedical academic research in Europe and the US for some years. Since 1997, he has been active in the medical device field. During eight years, Andrea worked at Swissmedic, the Swiss competent authority for therapeutic products, where he was responsible for the Medical Device Vigilance team. Since 2007, he has worked in the medical device industry, where he has held RA positions with roles in pre- and post-market functions.
Susana de Azevedo Wäsch, PhDVice President Quality Management & Regulatory Affairs & Medical Affairs, Ypsomed AG
Susana de Azevedo Wäsch is vice president of quality management and regulatory affairs with Ypsomed AG. She has more than 19 years of experience in medical devices, pharmaceuticals and biotechnology. Wäsch is experienced in the areas of regenerative medicine, implants, drug-device combination products and infusion pumps. Prior to Ypsomed, she worked at Geistlich Pharma AG, Switzerland; Eidgenössische Technische Hochschule Zürich; Lonza Visp, Switzerland; the European Bioinformatics Institute, Cambridge, England; and the Center for Advanced Research in Biotechnology in Rockville, MD, USA. After earning her MSc at the Ecole Supérieure de Biotechnologie Strasbourg, France, she performed her dissertation at the Institute of Microbiology at the Swiss Federal Institute of Technology in Zurich, followed by further training at the Executive School of Management, Technology and Law in St. Gallen, Switzerland.
Holiday Inn Munich – City Centre
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