3rd Annual FDA/MTLI Medical Device and IVD Statistics Workshop

Wednesday, April 28 – Thursday, April 29, 2010

Bethesda, MD | The Gaylord National


This annual conference, co-sponsored by FDA and AdvaMed-MTLI, brings together leading authorities from FDA, industry, and academia to address statistical issues specifically related to medical technology clinical studies, including Bayesian study design and analysis, subgroup analysis, multiple secondary endpoints, adaptive sample size re-estimation, patient-reported outcomes, and statistical challenges related to diagnostics and postmarket studies.

Sponsored by:

 

Co-Sponsored by:

 

 

 

Click here for the Full Agenda


Who Should Attend

Statisticians and clinicians involved in the pre- and postmarket assessment of medical devices and diagnostics


Registration
AdvaMed Member $995 Register Now
Non-Member $995
AdvaMed EGCC Member $995
Government $495

Agenda Overview
View Full Agenda
  • Non-inferiority
  • Bayesian Statistics
  • Blinding
  • Missing Data
  • Subgroup Analysis
  • Patient Reported Outcomes (including discussion of new guidance)
  • Risk/Benefit Analysis
  • Communication
  • Analytical Studies
  • Biomarkers/Microarrays
  • Open Discussion

Click here for the Full Agenda


Speakers

Joe Bero, Senior Manager, Biostatistics, Boston Scientific
Mark Rothmann, Ph.D., Team Leader, DBV/OB/CDER
Lilly Yue, Ph.D., Deputy Division Director, DBS/CDRH
Jim Rogers, PhD, Principal Statistician, Metrum Research Group (Metrum Institute)
Lurdes Inoue, Associate Professor, Biostatistics, University of Washington
Steve Skates, Ph.D., Harvard Medical School
Mitzan Mekel-Bobrov, Ph.D., Sr. Biostatistical Scientist, Neuromodulation, Boston Scientific Corporation
Heejung Bang, Ph.D., Associate Professor, Division of Biostatistics & Epidemiology Department of Public Health, Weill Medical College of Cornell University
Shiling Ruan, Ph.D., Mathematical Statistician, GSDB/DBS/CDRH
Yanping Chang, M.S., Medtronic
Joseph Massaro, Ph.D., Department of Mathematics and Statistics, Boston University
Gregory Campbell, Ph.D., Division Director, DBS/CDRH
Todd Gross, PhD, Senior Director, Biostatistics, Allergan Medical
Xiaogang Su, Ph.D., Associate Professor, Biostatistician, Department of Adult Health, SON, University of Alabama at Birmingham
Chul Ahn, Ph.D., Mathematical Statistician, CODB/DBS/CDRH BA
Jeff Sloan, Ph.D., Professor, Oncology and Biostatistics, Dept. Health Sciences Research, Mayo Clinic
Kristen Van Dole, Ph.D., Epidemiologist, Office of Surveillance and Biometrics, FDA/CDRH
Richard Chiacchierini, Ph.D., R.P. Chiacchierini & Associates
Melissa Simones, Boston Scientific
Roger Lewis, Ph.D., UCLA
Telba Irony, Ph.D., Branch Chief, CDRH/DBS/GSDB
Peggy Pereda, Boston Scientific
Gary Kamer, M.S. Mathematical Statistician, CODB/DBS/CDRH
Thomas Mathew, Ph.D., Professor, Department of Mathematics and Statistics, University of Maryland Baltimore County
Marina Kondratovich, Ph.D., Associate Director for Clinical Trials, Office of Personalized Medicine, OIVD/CDRH
Vicky Petrides, Abbott
James Garrett, PhD, Manager of the Bioinformatics, Algorithms, and Non-Clinical Statistics” group, BD Diagnostic Systems
Betty Stephenson, BD Bioscience
Estelle Russek-Cohen, Ph.D., Deputy Division Director, DB/OBE/CBER
Elliot Cowan, Ph.D. Branch Chief, DETTD/OBRR/CBER
Abha Sharma, Roche
Michael Pencina, Ph.D., Harvard Clinical Research Institute, Boston University
Steve Skates, Ph.D, Harvard Medical School
Yuying Jin, Ph.D. Mathematical Statistician, DDB/DBS/CDRH
Xuefeng Li, Mathematical Statistician, PhD, CDRH/DBS/GSDB
Alvin Van Orden, M.S., Mathematical Statistician, GSDB/DBS/CDRH

Click here for the Full Agenda

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General Information

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

Please be advised that any registrations received after 5 pm on Thursday April 8th will not appear on the participants roster.  It is MTLI policy not to release revised participants rosters after the seminar.

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 10 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 feew 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 Gaylord National Hotel
201 Waterfront Street
National Harbor, MD 20745
301-749-2073

A limited number of rooms have been reserved at this hotel for seminar participants, at the reduced rate of $199.  Please make your reservations by contacting the hotel at 301-965-4000 and identifying yourself as a member of the Advanced Medical Technology Association Statistics room block.  This rate will be available until March 28, 2010.  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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