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DTSTART;TZID=America/New_York:20191014T083000
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SUMMARY:Navigating through Maze of In-vitro Diagnostics (IVD) Regulations: A systematic approach from Regulatory Strategy to Regulatory Approvals in U.S./Europe/Canada
DESCRIPTION:Course Description:\nIn-vitro Diagnostics (IVD) products provide critical information on patient’s health condition\, based on which the healthcare provider develops and administers treatment plan. Although IVDs are medical devices\, they are regulated under a separate set of regulations in U.S.\, Europe\, and Canada. \nThis 2 day interactive course on in-vitro diagnostics is structured to understand the different set of IVD regulations\, how to navigate through this maze of IVD regulations\, and to win regulatory approvals. This In-vitro Diagnostics (IVD ) course will make the attendees understand the IVD regulations and develop regulatory strategies that secure regulatory approvals. \n Learning Objectives: \nAfter completion of this two day interactive course on IVD\, the attendee will be able to: \n\nUnderstand why IVD is regulated differently.\nAn overview of IVD Regulations – U.S. FDA.\, Europe (MDD)\, Canada.\nDevelop Regulatory Strategies and determine Regulatory Pathways.\nInclusion and exclusion of data and information for different submission.\nFormat and Content of premarket submissions.\nProduct Label and Labeling for IVDs.\nWorking and interacting with the reviewers and regulators.\nTips and Suggestions to secure rapid regulatory approvals.\n\n\nWho will benefit:\nThis interactive course is specifically developed for individuals\, who are responsible for the design\, development\, manufacturing\, marketing\, and distribution of IVD products. This course is highly recommended for personnel involved in any of the following functions: \n\nDepartment Managers (middle management)\nResearch & Development (R&D)\nProduct Design & Development\nValidation Engineering\nRegulatory Affairs\nQuality Assurance\nQuality Control\nManufacturing/Production\n\nSpeaker: \nRobert Di Tullio\nPresident\, Di Tullio Consulting Inc \nRobert Di Tullio is an experienced leader in the diagnostics industry. For 45 years\, he has held various positions with multiple organizations\, with a particular emphasis on regulatory\, quality and clinical affairs management. \nRobert has provided companies\, large\, small and start-up\, with the vision\, strategy and leadership to promote commercial success while assuring compliance with global regulations and initiatives in the competitive marketplace. \nAs a solutions oriented leader\, Robert has consistently achieved positive results in all industry aspects for regulatory and operational processes and systems. \nFor Registration – https://www.complianceonline.com/in-vitro-diagnostics-ivd-regulatory-approvals-in-us-europe-canada-seminar-training-80148SEM-prdsm?channel=eventbrite \n\nNote: Use coupon code < REFERRAL10 > and get 10% off on registration.
URL:https://scienceinboston.com/event/navigating-through-maze-of-in-vitro-diagnostics-ivd-regulations-a-systematic-approach-from-regulatory-strategy-to-regulatory-approvals-in-u-s-europe-canada/
LOCATION:ComplianceOnline\, Boston\, MA\, 02111\, United States
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20191014T083000
DTEND;TZID=America/New_York:20191014T163000
DTSTAMP:20190909T151047Z
CREATED:20190909T151047Z
LAST-MODIFIED:20190909T151047Z
UID:27337-1571041800-1571070600@scienceinboston.com
SUMMARY:Navigating through Maze of In-vitro Diagnostics (IVD) Regulations: A systematic approach from Regulatory Strategy to Regulatory Approvals in U.S./Europe/Canada
DESCRIPTION:Course Description:\nIn-vitro Diagnostics (IVD) products provide critical information on patient’s health condition\, based on which the healthcare provider develops and administers treatment plan. Although IVDs are medical devices\, they are regulated under a separate set of regulations in U.S.\, Europe\, and Canada. \nThis 2 day interactive course on in-vitro diagnostics is structured to understand the different set of IVD regulations\, how to navigate through this maze of IVD regulations\, and to win regulatory approvals. This In-vitro Diagnostics (IVD ) course will make the attendees understand the IVD regulations and develop regulatory strategies that secure regulatory approvals. \n Learning Objectives: \nAfter completion of this two day interactive course on IVD\, the attendee will be able to: \n\nUnderstand why IVD is regulated differently.\nAn overview of IVD Regulations – U.S. FDA.\, Europe (MDD)\, Canada.\nDevelop Regulatory Strategies and determine Regulatory Pathways.\nInclusion and exclusion of data and information for different submission.\nFormat and Content of premarket submissions.\nProduct Label and Labeling for IVDs.\nWorking and interacting with the reviewers and regulators.\nTips and Suggestions to secure rapid regulatory approvals.\n\n\nWho will benefit:\nThis interactive course is specifically developed for individuals\, who are responsible for the design\, development\, manufacturing\, marketing\, and distribution of IVD products. This course is highly recommended for personnel involved in any of the following functions: \n\nDepartment Managers (middle management)\nResearch & Development (R&D)\nProduct Design & Development\nValidation Engineering\nRegulatory Affairs\nQuality Assurance\nQuality Control\nManufacturing/Production\n\nSpeaker: \nRobert Di Tullio\nPresident\, Di Tullio Consulting Inc \nRobert Di Tullio is an experienced leader in the diagnostics industry. For 45 years\, he has held various positions with multiple organizations\, with a particular emphasis on regulatory\, quality and clinical affairs management. \nRobert has provided companies\, large\, small and start-up\, with the vision\, strategy and leadership to promote commercial success while assuring compliance with global regulations and initiatives in the competitive marketplace. \nAs a solutions oriented leader\, Robert has consistently achieved positive results in all industry aspects for regulatory and operational processes and systems. \nFor Registration – https://www.complianceonline.com/in-vitro-diagnostics-ivd-regulatory-approvals-in-us-europe-canada-seminar-training-80148SEM-prdsm?channel=eventbrite \n\nNote: Use coupon code < REFERRAL10 > and get 10% off on registration.
URL:https://scienceinboston.com/event/navigating-through-maze-of-in-vitro-diagnostics-ivd-regulations-a-systematic-approach-from-regulatory-strategy-to-regulatory-approvals-in-u-s-europe-canada-2/
LOCATION:ComplianceOnline\, Boston\, MA\, 02111\, United States
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