Postmarketing Vigilance Reporting For Medical Device Manufacturers
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Major postmarketing vigilance revisions are now in force. A revised medical device guidance document on postmarketing vigilance (MEDDEV 2.12-1 rev 6) 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:
Who Will Benefit:
- 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
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
- Engineering/Technical Services/Operations
David R. Dills, is Director of Regulatory Services at CROMSOURCE, an international contract research organization (CRO) to the pharmaceutical, biotechnology, and medical device industries. Mr. Dills has more than 28 years of experience in the medical device and pharmaceutical industry.
He has held positions of increasing responsibility with sponsor and service companies of various sizes, including large, global OEM's/sponsors, consultancies and a global CRO, as well as virtual, small, mid and large-sized enterprises and has serviced sponsors and clients in multiple global locations.
Mr. Dills most recent position was President and Principal, Global Regulatory Affairs Consultant with a consultancy in the US, and prior to that he served in senior level regulatory and compliance roles for various organizations.
He has a range of expertise in different therapeutic areas and medical specialties for pharma and medical devices, including combination products.
David enjoys interpreting the regulatory precedents and new legislation, developing the regulatory strategy as part of strategic regulatory consulting, Agency meeting preparation and engagement, conducting persuasive communication with regulatory authorities, executing an effective path to approval for submissions and marketing applications with multi-country registrations and approvals, developing GxP compliance strategies from premarketing to postmarketing from R&D, Manufacturing/Operations, Postmarket and to delivering regulatory and compliance training to internal and external stakeholders, and striving for overall corporate compliance with regulations in The Americas, EMEA and Asia Pacific.
He has managed regulatory and compliance projects with multiple competing priorities having a direct impact on site operations commercial opportunities and enjoys adding business value to clients by providing strategic and tactical solutions that facilitate the achievement of regulatory and compliance milestones and on minimizing delays due to noncompliance and regulatory risk.
He has worked directly with global manufacturers and sponsors engaged in compliance remediation activities and services involving enforcement actions and customer generated compliance events, inspection preparation, among other regulatory and compliance responsibilities.