9th Annual FDA/AdvaMed Medical Devices and Diagnostics Statistical Issues Conference

May 03 – 04, 2016, Arlington, VA

Overview |  Agenda |  Speakers |  Logistics |  Fees


The event, Statistical Methods in Economic Evaluations Workshop , will be held the day prior to the statistics conference. This workshop is considered Day "0" to the conference, and many professionals attend both events.  You can learn more and register for the workshop here.

This annual conference brings together leading authorities from FDA, industry and academia to address statistical topics through two tracks- therapeutic device and diagnostics. 

Session topics include:

Day 1

  • Keynote Lecture - Designing the Evidence Generation System of the Future - Gregory Campbell, Ph.D., Principal Statistician, GCStat Consulting
  • Use of Real-World Evidence for Regulatory-Decision Making
  • FDA Guidance Update, Including EAP – Regulatory Review Pathway
  • Subgroup Analyses

Day 2 Therapeutic Track

  • Statistical Challenges in Recurrent Events
  • Study Design Considerations for Non-Randomized Studies: Practical Issues When
    Using Objective Performance Criteria (OPC) Performance Goal (PG) and
    Propensity Score Method
  • Multiplicity Issues, Including Multi-Region, Multiple Endpoints, Repeated Measures
  • Listening to the Patients: Case Studies Incorporating Patient-Reported Outcomes
    and Patient Preference Information into FDA Submissions

Day 2 Diagnostics Track

  • Statistics for Advanced Diagnostic Technologies: Next Generation Sequencing,
    Immunohistochemistry and Quantitative Imaging Biomarkers
  • Clinical studies: Good Validation Practices
  • Equivalence
  • Expanded Applications of CLSI Guidelines

Co-sponsored by:

This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.


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Keynote Speaker:
Gregory Campbell, Ph.D.

Gregory Campbell has served as the Director of the Division of Biostatistics in the Office of Surveillance and Biometrics of Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) for 20 years until he retired from the U.S. government in the summer of 2015. With undergraduate and graduate degrees in Mathematics, he earned a Ph.D. in Mathematical Statistics from Florida State University. After serving on the faculty in the Department of Statistics at Purdue University, he joined the National Institutes of Health, where he became a tenured intramural research scientist, Section Chief and Acting Lab Chief. In his position at FDA, Dr. Campbell led a group of about 65 statisticians that provided support to CDRH as a whole and, in particular, the statistical reviews of FDA’s pre-market device submissions that led to the approval of a large number of innovative medical devices and diagnostics. For more than 15 years he served in the prestigious Senior Biomedical Research Service (SBRS) in the Department of Health and Human Services. He pioneered the innovative implementation in a regulatory environment of Bayesian statistics, methods for observational studies, and adaptive designs. His research interests include the evaluation of diagnostic tests (including microarrays) as well as statistical issues in clinical trials. The author of more than 100 scientific publications, he serves as Associate Editor for Statistics in Biopharmaceutical Research. He is a Fellow of the American Statistical Association and recipient of the FDA Award of Merit, the CDRH Diversity Award and the Outstanding Scientific Award for Excellence in Analytical Science. Dr. Campbell served in leadership positions for the Eastern North American Region of the International Biometric Society and the Society for Clinical Trials and has been instrumental in the recent establishment of the Medical Device and Diagnostics Section of the American Statistical Association.

Hotel & Meeting Logistics

Renaissance Arlington Capital View Hotel
2800 South Potomac Ave, Arlington, VA, 22202
(703) 413-1300

The room block is now closed.  Please call (703) 413-1300 for availability.

Registration Fees

AdvaMed Member Registration: $1,295.00
Accel Member Registration: $695.00
FDA Registration (1 day): $195.00
FDA Registration (both days): $350.00
Non-Member Registration: $1,295.00

Please contact ssmith@advamed.org for Group Discounts.