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xtalks.com, webinar
Thursday, March 24, 2022 | 9am EDT (NA) / 1pm GMT (UK) / 2pm CET (EU-Central)
Who Should Attend?This webinar will appeal to professionals in the medical device industry, including VPs/Directors/Managers of: - Clinical
- Clinical Affairs
- Medical Affairs
- R&D
- Regulatory
What You Will LearnRegister for this webinar to: - Gain understanding of the increased clinical data requirements under the EU MDR, particularly in relation to PMCF.
- See how defining and planning appropriate strategies to meet requirements under the EU MDR requires a multidisciplinary approach.
- Hear NAMSA experiences to date from multiple manufacturers and notified bodies.
- Learn the challenges other manufacturers may face and possible solutions.
- Understand that EU MDR submissions need to be carefully planned without waiting for the end of the transition period in May 2024.
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Organized by:
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xtalks.com |
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Invited Speakers:
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Speakers Adrian Keene, BSc (Hons), Senior Director, Global Biological Safety and Validation and EMEA Consulting Services, NAMSAWith 29 years of experience in the medical device industry, Adrian’s knowledge of new product development combined with EU regulatory requirements enables him to provide a balanced interpretation of the needs and expectations of Notified Bodies, competent authorities and manufacturers. His current responsibilities at NAMSA involve leading the regulatory, quality and biological evaluation teams — working with a broad range of devices including drug-device combination products. Prior to working at NAMSA, Adrian was Head of Notified Body for the UK Notified Body SGS, and spent 10 years in the notified body sector, where he was responsible for conformity assessment activities of high risk (class III) devices. He is a toxicologist by training and worked for a number of years in the medical device industry in research and development, providing toxicological and risk management strategies to expedite product launches for multiple global registrations. Message PresenterJane Arnold-Round, Principal Regulatory Scientist, NAMSAJane Arnold-Round has 30 years of experience in the medical device industry working with a broad range of medical device technologies and organizations from start-ups to multinationals. Jane began her career with Medtronic and then Sulzer Vascutek before joining BSI in 2000 where responsibilities included conducting Product Conformity Assessments against the requirements of the European Directive 93/42/EEC. While at BSI, her time was dedicated to products utilizing animal tissues, device-drug combination devices and high-risk wound care products. Following these positions, Jane joined NAMSA in regulatory consulting where she focuses on partnering with manufacturers of high-risk, Class III devices to achieve regulatory approval. Message PresenterSara Finocchietti, Senior Clinical Study Manager, NAMSASara Finocchietti serves as Senior Clinical Study Manager at NAMSA, managing both pre- and post-market studies. She has over 10 years’ experience in clinical affairs and management in the medical device domain. She has been working with a wide range of organisations, from start-ups, SMEs, and public research entities, bringing innovative products to market or supporting existing portfolios. She was notably Clinical Affairs Manager for a French orthopaedic manufacturer, responsible of the company’s clinical strategy and study management. Sara has extensive experience of working within cross-functional and cross-cultural teams. She holds a master’s degree in Biomedical Engineering from Italy and a PhD in Clinical Science from Denmark. |
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Deadline for Abstracts:
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Registration:
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Clinical Challenges under the EU MDR - Xtalks
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E-mail:
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shunte@xtalks.com
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