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Overview: Major postmarketing vigilance revisions are now in force. A revised medical device guidance document on postmarketing vigilance (MEDDEV 2.12-1 rev 5) came into force on January 1, 2008. Providing more guidance than the previous version, the new document includes new reporting terminology and concepts such as "periodic summary reporting" and "trend reporting." In addition, the terms "advisory notice," "near incident," and "recall" have been eliminated or replaced. Although MEDDEVs are not legally binding, it is likely that all European Competent Authorities will follow the new guidelines and will expect organizations involved in the management and reporting of adverse incidents to follow them as well. This session will address topics such as new definitions; the guideline's extended scope, reporting criteria/timelines, filing safety notices and field safety corrective actions, and more. The new guidelines contain some controversial aspects, including the extension of their scope and the new approach of immediate reporting unless delays can be justified. However, they also provide additional clarity and more-detailed advice in many areas. The European Database EUDAMED also is described. Periodic or trend reporting under certain conditions is now allowed, as a result of the integration of certain GHTF concepts. Although a transition period was allowed until the end of 2007, the revised guidelines will undoubtedly result in the need for manufacturers, authorized representatives, and distributors to make changes to their SOPs and other documents. Areas Covered in the Session: Examine the latest changes to MEDDEV and Medical Device Vigilance and impact on medical device manufacturers Recognize the "new" terminology and concepts Report incidents as recommended by the guidance Examine why Global Harmonization Task Force (GHTF) is an integral component of the new postmarketing vigilance guidelines Manage expectations for reporting and timelines Recognize which amendments impact the European vigilance system Interpret the new guidelines that cover incidents involving devices that carry the CE mark and devices that do not carry the CE mark Submit periodic summary reports of incidents to Competent Authorities Examine controversial aspects of the guidelines, including the extension of their scope and the new approach of immediate reporting unless delays can be justified Identify the conditions under which reporting is not required and why they have been expanded and clarified with no significant changes, although one reason has been removed Who Will Benefit: This webinar will provide valuable assistance and guidance to device companies in involved in vigilance reporting. Employees who will benefit include: All levels of management and departmental representatives and those who desire a better understanding or a "refresh" overview Regulatory Affairs Clinical Affairs Quality and Compliance Marketing & Sales Distributors Engineering/Technical Services/Operations Consultants David R. Dills, an independent Regulatory & Compliance Consultant with more than 22 years of hands-on experience and a proven track record within the FDA regulated industry, has an extensive regulatory and compliance background with Class I/II/III and IVD devices and managing and handling activities within the global regulatory and compliance landscape. He manages quality, regulatory and compliance projects with multiple competing priorities having a direct impact on site operations and commercial opportunities and develops strategies for governmental approval to introduce new products to market, provides guidance and direction on regulatory and compliance requirements and prepares/reviews worldwide submissions/dossiers/technical files and addresses requirements in the EU, Pacific Rim and The Americas regarding all aspects of device commercialization and especially FDA activities. Background encompasses broad capabilities in quality systems, validation, regulatory affairs, GxP compliance, auditing, interfacing with the regulatory agencies, managing enforcement actions and mitigating compliance exposure for companies, working with Notified Bodies, AR’s and demonstrates credible experience to maximize business performance in the devices arena. He strives to optimize business performance through proactive strategies to mitigate compliance exposure by providing strategic and tactical solutions that facilitate the achievement of regulatory milestones. David has been previously affiliated with well-known device manufacturers and service providers, including a well-known CRO and has served in various quality, regulatory and compliance management and advisory capacities with increasing responsibilities. David is an accomplished industry speaker and author of technical and compliance related topics published in industry journals. Please refer to his profile provided herein for additional information about his background. Webinar By GlobalCompliancePanel Price List: Live : $245.00 Corporate live : $495.00 Recorded : $295.00 Phone: 800-447-9407 Fax: 302-288-6884 webinars@globalcompliancepanel.com http://www.globalcompliancepanel.com 1000 N West Street Suite 1200 Wilmington DE USA 19801 AMAZINES.COM
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online training, Postmarketing Vigilance Reporting, MEDDEVs, Global Harmonization Task Force, European vigilance system,
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