eMDR Implementation: A Practical Guide
Presented as the recording of Virtual Conference (webcast):  
Originally broadcasted on Wednesday, October 5, 2011, 11:00 am to 2:30 pm EST

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 Speakers:

• Eugene Reilly, eMDR Coordinator, Office of Surveillance & Biometrics, CDRH/FDA  

• Richard C. Roy, Senior MDR Manager, Medtronic CDRM

• Patrick Caines, Ph.D., MBA, Director, Corporate Postmarket Surveillance, Boston Scientific

• Deborah Kacera, Industry Solutions Director, Pilgrim Software

• Paul Eaton, Principal Quality Engineer, Boston Scientific

• Moderator: Thomas Maeder, Conference Director, MedicalDeviceSummit

Webinar Background:  Electronic Medical Device Reporting (eMDR) allows electronic data entry and processing of medical device adverse event reports.  After several delays, the electronic reporting route is likely to become mandatory in 2012, after which paper submissions will no longer be accepted.
 
In this webinar, experts from industry and FDA will cover the practical information you need to begin implementing an eMDR system, how to decide which of the two reporting routes to select, steps for setting up and testing your system and account, typical challenges and solutions, and where to go for further information.
 
Conference Agenda October 5th:
 
1.  eMDR Implementation: Overview
the Regulation, System, and Practical Considerations
 
This first track reviews the regulation, technology, and two eMDR submission options, looking at a broad range of FDA and early adopter experiences, with lessons to be learned and suggested additional resources.
 
2.  eMDR Implementation: Low Volume Reporting
the FDA eSubmitter and WebTrader Option  
 
For low volume reporters, the free eSubmitter application and a WebTrader account allow submission of individual MDRs.  This option also provides a valuable back-up enabling high volume reporters to submit critical MDRs if their regular system is down.

This webinar combines practical industry experience in creating and switching to a low volume eMDR system with a live FDA demonstration of the eSubmitter and WebTrader technologies and their use.
 
3.  eMDR Implementation: High Volume Reporting
the AS2 Business-to-Business Compliant Option
 
High volume reporting companies are likely to use the AS2 compliant B2B submission option.  This webinar provides a case study in practical implementation of the technical systems, and allocation and coordination of internal resources.

How does the high volume option differ from that for low volume reporters, and what have been the user experiences, glitches, and solutions.

4.  Round Table Discussion
Open discussion among all the speakers and panelists. 

Format:   

• Registration is $395, additional team members are $345.  The registration includes all three sessions and round table discussion.

• After successfully registering, you will receive a link to the archived recording of the event allowing you to watch the webinar "On Demand"  as often as you like.  

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