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BEGIN:VEVENT
DTSTART:20210414T200000Z
DTEND:20210414T210000Z
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SUMMARY:Innovative Product Regulatory Strategies for Medical Devices and IVDs
DESCRIPTION:As the global medical practice undergoes drastic change embracing faster access to innovative technologies\, getting the regulatory strategy right from the onset can mean the difference between success and failure. In this webinar\, we discuss the key considerations for registering innovative products and changes to existing products incorporating innovative modifications. We will focus on the current regulatory issues and requirements when evaluating alternative pathways for TGA\, EU\, and US including rare-disease designations\, priority review\, and provisional approvals. Special note will be taken on how the MDR and IVDR transitions are impacting innovative product registrations and product changes. Key trends such as the use of Real-World Evidence\, MDSAP\, and risk-based biocompatibility management will be discussed.\n\n\n\nPresenter: Luis Jimenez\, Brandwood CKC\n\n\n\nRegister to receive this pre-recorded webinar to your inbox as below:\n\n\n\nWednesday 14 April\n\n2pm USA Pacific / 5pm USA EDT
X-ALT-DESC;FMTTYPE=text/html:As the global medical practice undergoes drastic change embracing faster access to innovative technologies\, getting the regulatory strategy right from the onset can mean the difference between success and failure. In this webinar\, we discuss the key considerations for registering innovative products and changes to existing products incorporating innovative modifications. We will focus on the current regulatory issues and requirements when evaluating alternative pathways for TGA\, EU\, and US including rare-disease designations\, priority review\, and provisional approvals. Special note will be taken on how the MDR and IVDR transitions are impacting innovative product registrations and product changes. Key trends such as the use of Real-World Evidence\, MDSAP\, and risk-based biocompatibility management will be discussed.<br />\n<br />\n<strong>Presenter: </strong>Luis Jimenez\, Brandwood CKC<br />\n<br />\n<a href="https://bit.ly/3rGdOQY" target="_blank">Register to receive this pre-recorded webinar to your inbox as below:</a><br />\n<br />\n<strong>Wednesday 14 April</strong><br />\n2pm USA Pacific / 5pm USA EDT
LOCATION:
UID:e.9284.5482
SEQUENCE:3
DTSTAMP:20260410T213626Z
URL:http://devbioutah.memberzone.com/events/details/innovative-product-regulatory-strategies-for-medical-devices-and-ivds-5482
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