6th Annual FDA/MTLI Medical Devices and IVD Statistical Issues Workshop

April 23 – 24, 2013 — Sheraton Crystal City, Arlington, VA

Overview |  Agenda |  Speakers |  Logistics |  Fees


This annual conference, co-sponsored by FDA and AdvaMed, brings together leading authorities from FDA, industry, and academia to address statistical topics such as:
- An overview of clinical study data management
- Roles of data standards with a focus on the recently released CDISC-device domains
- ADaM analysis datasets for devices
- The impact of the Food and Drug Administration Safety and Innovation Act (FDASIA) and MDUFA III on the pre-submission process
- Recent developments in the sample size estimation and re-estimation area
- Adaptive designs with sample size re-estimation feature
- The Bayesian adaptive design CRADA software with the sample size estimation and re-estimation feature

Hear from Keynote Speaker – Andrew W. Lo, PhD, Charles E. and Susan T. Harris Professor and Director, Laboratory for Financial Engineering, Massachusetts Institute of Technology

On Day 2 the conference will be split into focus areas
Therapeutic Device Track addressing:
- Use of simulation to estimate the operating characteristics of clinical trials
- Use of registries (including unique device identifiers (UDI) and electronic health records (EHR) in pre- and post-market studies
- Data monitoring committees in classical and adaptive trials of medical devices
- Issues of pooling in clinical studies

Diagnostics Track addressing:
- Performance standards for combination products
- A report from the Equivocal Results Sub-Group
- IVD guidances and standards
- Next Generation Sequencers as IVDs: What statisticians need to know

Register today and receive a $150 discount code for the Design and Analysis Challenges for Pediatrics and Rare Diseases. Please email skinchen@advamed.org to receive your discount code.

-offer does not include EGCC, Government, and Non Profit organizations

Co-sponsored by:


“This continues to be very useful for me as it is the only conference that brings FDA and industry together specifically in the medical device arena. It is relevant content and great for networking. If I can make only one conference in a particular year it will be this one.”

"As a non-statistician, medical monitor I found the information quite useful in exposing me to the current challenges in medical device regulatory statistics, as well as, potential solutions from the regulatory, industry and academic perspective."

"I am new to the medical device industry; I thought that this conference provided a good overview of the current statistical issues/challenges related to submissions for & communications regarding medical device products to the FDA."

Make your hotel reservations by clicking on the Sheraton Crystal City Hotel logo below:


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Keynote Speaker:
Andrew W. Lo, PhD, Charles E. and Susan T. Harris Professor and Director, Laboratory for Financial Engineering, Massachusetts Institute of Technology

Ashley Boam, Acting Associate Director for Regulations and Guidance, FDA
Greg Campbell, Director of Biostatistics, FDA
Martin Ho, Mathematical Statistician, FDA
Telba Irony, Chief, General and Surgical Devices Branch - Division of Biostatistics, FDA
Heng Li, Mathematical Statistician, FDA
Danica Marinac-Dabic, Director, Division of Epidemiology, FDA
Gene Pennello, Team Leader, Division of Biostatistics, FDA
Ted Peterson, ORISE Fellow, FDA/CDRH
Estelle Russek-Cohen, Director, Division of Biostatistics, FDA
Xiting Yang, FDA
Lilly Yue, Deputy Director, Division of Biostatistics, FDA
Donald Berry, Professor, Department of Biostatistics, The University of Texas MD Anderson Cancer Center
Scott Berry, President & Senior Statistical Scientist, Berry Consultants
Jeffrey Budd, Senior Staff Biostatistician, Beckman Coulter
Nate Freimark, Senior Director, Biometrics Operating Standards Group, Theorem Clinical Research
Kit Howard, Independent Consultant
Semyon Kruglyak, Senior Director, Research Informatics, Illumina
Peter Lam, Boston Scientific
Vince Magrini, The Genome Institute at Washington University
Joe Massaro, Assistant Professor of Biostatistics, Mathematics and Statistics, Boston University
Cyrus Mehta, Cytel, Inc.
Andy Mugglin, Research Associate Professor of Biostatistics, University of Minnesota
Jim Pierson-Perry, Senior Key Expert, Global Assay Development, Siemens Healthcare Diagnostics
Judith Quinlan, Senior Vice President, Adaptive Trial Design & Implementation, Aptiv Solutions
Michael Steinbuch, Global Head of Product Vigilance, Procter & Gamble Co.
Roseann White, Senior Director, Global Biometrics, Abbott Vascular
Members of the Equivocal Results Task Group

Hotel & Meeting Logistics

Sheraton Crystal City
1800 Jefferson Davis Highway
Arlington, VA  22202

Reservations:  1-888-627-8209 (Reference AdvaMed when making reservations)
or online at:

Room rate:  $289.00  
Rate available 3 days prior/post meeting based on hotel availability
Hotel cut-off date for reservations:  4/05/13

Registration Fees

AdvaMed Member Registration: $1,095.00
Accel Member Registration: $695.00
Government and Non-Profit Registration: $395.00
Non-Member Registration: $1,095.00

Please contact ssmith@advamed.org for Group Discounts.