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:
- 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
- Engineering/Technical Services/Operations
Not sure if you want to exhibit at or attend the Webinar on Medical Device Postmarketing Vigilance Reporting: Update and Expectations for Manufacturers? See the panels below to get the information you need to make an informed decision.
|Conference/Event Dates:||10/28/2015 - 10/28/2015|
|Conference/Event Hours:||60 Minutes|
|Other Industries:||Manufacturing, Medical|
|Cost to Attend:||http://bit.ly/1PDfpPr|
|Audience:||All levels of management and departmental representatives and those who desire a better understanding or a "refresh" overview
Quality and Compliance
Marketing & Sales
|Sponsorship Details:||NetZealous LLC DBA Compliance4All,
161 Mission Falls Lane, Suite 216,
Fremont, CA 94539, USA.
|Booth Size||Booth Cost||Available Amenities|
|Marketing Vehicles Allowed:||n/a|
|Other Booth Sizes Available: n/a|
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David R. Dills, Regulatory Affairs & Compliance Consultant currently provides regulatory, compliance and quality consultative services for medical device and pharmaceutical/combination manufacturers, and also has an accomplished record with more than 24 years of experience with Class I/II/III medical devices, In Vitro diagnostics, and pharmaceuticals in the areas of Regulatory Affairs, Compliance and Quality Systems. He has been previously employed, with increasing responsibilities by medical device manufacturers and consultancies, including a globally recognized CRO.
Since 2000, has provided consultative services on behalf of manufacturers and subcontracted by third-party consultancies and provides services involving all phases of the product development, submission, and commercialization process; Agency inspection readiness preparation and remediation; preparing Agency responses due to enforcement actions; conducting audits and assessments and preparing CAP/remediation plan; compliance engineering support, regulatory planning; post-marketing surveillance and vigilance reporting; clinical affairs, establish and/or remediate Quality Management and documentation systems for GxP compliance; preparation for ISO 13485 registration and CE Mark; and multi-country product registrations and licensing.