MDRs, eMDRs, and Global Adverse Event Reporting

Monday, November 09 – Tuesday, November 10, 2009

Washington, DC Metro Area | The Westin Arlington Gateway


SPECIAL PROMOTION - Please do not submit your registration online, we will do it for you!

AdvaMed's MTLI is offering a $250 discount on all remaining 2009 courses. In order to obtain the $250 discount, please visit our website at www.advamedmtli.org and complete the registration form but do no submit it online.

After completing your registration form, PDF the form and email it to kkunze@advamed.org or print it out and fax it to 202.783.8750 Attention: Katia. Please indicate your request for the $250 discount in the body of the email or the fax cover sheet and we'll take it from there. Some restrictions may apply.

COURSE DESCRIPTION
This two-day program, offered each Fall, covers current practical and policy issues in US and international adverse event reporting.  The most recent program helped launch FDA’s new electronic reporting procedures, but the content changes annually according to regulatory developments and industry needs.

 

Click here for the Full Agenda


Who Should Attend
Those persons involved with Regulatory Affairs, Postmarket Safety Monitoring, Adverse Event Reporting, Medical Officers, and Recall Coordinators.

Registration
AdvaMed Member $1295 Register Now
Non-Member $1915
AdvaMed EGCC Member $1095
Government $495

Agenda Overview
View Full Agenda
Medical Device Reporting - 21 CFR Part 803
What Does FDA Do with the Data
Coding
Panel Discussion and Q&A on MDR Principles
Implementing MDR Requirements
The Shift to Electronic Communications
eMDR Implementation
Health Hazard Evaluation and Risk Assessment
Global Adverse Event Reporting
MDRs and the Link to Inspections and Enforcement Actions
What Can Be Done Better

Click here for the Full Agenda


Speakers

Invited Speakers:
Sharon Kapsch, Director, Reporting Systems Monitoring Branch, Office of Surveillance & Biometrics, FDA/CDRH
Howard Press, Policy Analyst, Office of Surveillance & Biometrics, FDA/CDRH
David Buckles, Director, Division of Postmarket Surveillence, Office of Surveillance & Biometrics, FDA/CDRH
Terrie Reed, Project Manager, Patient Safety Staff, Office of Surveillance & Biometrics, FDA/CDRH
Kathy Weil, Nurse Consultant, FDA/CDRH
Richard Roy, Technical Services Manager, AGA Medical Systems
Stephen Sykes, Deputy Director, Office of Surveillance & Biometrics, FDA/CDRH
Indira Konduri, eMDR Program Manager, Office of Surveillance & Biometrics, FDA/CDRH
Kimber Richter, Deputy Director for Medical Affairs, Office of Compliance, FDA/CDRH
Leighton Hansel, Director, Regulatory Affairs, Abbott Laboratories
David Buckles, Director, Division of Postmarket Surveillance, Office of Surveillance & Biometrics, CDRH
Naunihal Virdi, MD, FACP, LifeScan
Deb Kacera, Senior Product Manager, Regulatory Products, Pilgrim Software
Monique Brooks, Recall Coordinator, FDA/CDRH



Click here for the Full Agenda

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General Information

Please be aware that registrations that are received after 5 pm on Monday, October 26, 2009 will not appear in the participants roster distributed to all attendess at the Seminar.  It is MTLI policy not to release participants rosters after the conclusion of the seminar.

It is the responsibility of the registrant to verify their company’s active membership status prior to registering.  You may check if your company is an active member by clicking here .  There will be no adjustments or refunds made for registrations made as non-members, when registrant’s company is a member company.  Higher non-member rate will be charged for registrations received under member registration when companies are found to be non-members.

For Sponsorship Opportunities and Seminar Logistics, please contact Veronica Allen.  For information regarding Registration issues, please contact Katia Kunze.

CANCELLATION & REFUND POLICY

All cancellations must be received in writing by Katia Kunze. All cancellations received 11 business days or more prior to the start of the program are subject to a ten percent cancellation fee. There will be NO REFUNDS for cancellations received within the 10 business days prior to the start of the program including "no shows".

We welcome substitutions in lieu of cancellations at any time. Please contact Katia Kunze with the substitute's information. All cancellation refunds will be processed within 30 business days from date cancellation request is received.  Topics and speakers are subject ot change without notice. 
Advamed reserves the right to cancel or reschedule any program, whereupon full registration fee will be refunded or applied to the rescheduled program in accordance with the registrant's preference. In the event of cancelled programs, AdvaMed assumes no responsibility, for transportation, hotel, or   other expenses incurred by registrants.

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Location Information

The Westin Arlington Gateway
801 North Glebe Road
Arlington, VA 22203
703.717.6200

A limited number of rooms have been set aside for attendees to the MDrs, eMDRs seminar, at the discounted rate of $179. To make reservations, please contact the hotel at 703.717.6200 and identifying yourself as a member of the Advanced Medical Technology Association room block or click on the hotel link above. This rate will be available until Thursday, October 22. Room and rates are subject to availability after this date. Please make your reservations early as the block will fill up quickly.

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Frequently Asked Questions

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