edical Device Postmarketing Vigilance Reporting: Update and Expectations for Manufacturers - Webinar By GlobalCompliancePanel

Event Details

Time: May 9, 2013 from 10am to 11am
Location: Online Training
Street: 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA
City/Town: Fremont
Website or Map: http://bit.ly/108vCQh
Phone: 8004479407
Event Type: webinar, healthcare, medical, device, pharmaceutical, clinical
Organized By: GlobalCompliancePanel
Latest Activity: Apr 29, 2013

Export to Outlook or iCal (.ics)

0 members like this

Event Description

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.
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.

Who Will Benefit:

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.

Price: $245.00

GlobalCompliancePanel

NetZealous LLC,
161 Mission Falls Lane,
Suite 216, Fremont, CA 94539, USA
USA Phone:800-447-9407
Fax: 302-288-6884
webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com

Registration Link