Webinar: eMDR & the New Electronic FDA – June 24, 2009

The FDA is spending billions of dollars on IT modernization and standardization, so could this finally be the year they mandate eMDR?

The pace of eMDR adoption is also starting to pick up steam. Medical device manufacturers are typically considered early technology adopters but during 2006-2007 (see chart below), eMDR submissions stayed relatively unchanged year over year. However, starting in 2008 electronic submissions more than doubled, and will most likely at least triple this year. At the end of 2008, 11% of MDRs came via eMDR.

So is it time to start thinking about transitioning to eMDR? Most likely say experts from the FDA. According to Indira Konduri, “Get an early start now. We’re here to help and give personalized attention. Assistance from the FDA will be easier now — before it’s mandatory — and you’ll be ready to go when when eMDR is mandated.”

About the Webinar:

Date: Wednesday, June 24, 2009
Time: 10:00 am – 11:00 am Pacific
To request recorded viewing of this event: http://www.assurx.com/eMDRJune09Webinar.html

AGENDA:

Understanding Electronic Medical Device Reporting (eMDR)
What the FDA is saying about eMDR and the options available to you today
Making the switch from manual to fully automated electronic reporting
The FDA’s ESG and how it works for both low and high volume submitters
The FDA’s $2.5 billion commitment to IT modernization (and standardization)
The FDA’s push for eMDR with the implementation of their new unified electronic system — FAERS
A closer look at MedWatch Plus Portal
The benefits of true eMDR and developing an effective strategy

TRUE eMDR IN ACTION LIVE DEMONSTRATION

Q&A SESSION

Get your eMDR questions addressed by the experts in a Q&A forum

WHO SHOULD ATTEND:

Regulatory Affairs and Compliance
Quality Management
Product Surveillance
Information Technology

To request recorded viewing of this event: http://www.assurx.com/eMDRJune09Webinar.html

All attendees will also receive the newly updated 3rd Edition of the eMDR eBook “Leveraging the Benefits of eMDR: A Guide to Improved Operations with Electronic Medical Device Reporting”.