Medical Devices

Workshop - 9th Annual Medical Device and Diagnostics Statistical Issues, Co-Sponsored by AdvaMed and FDA, May 3-4, 2016

The Food and Drug Administration (FDA) and the Advanced Medical Technology Association (AdvaMed’s) Medical Technology Learning Institute (AdvaMed/MTLI) is announcing a co-sponsored two-day Workshop to be held on May 3-4, 2016.

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 - Robert M. Califf
  • Use of real-world evidence for regulatory-decision making, including data quality, missing data issues, health technology assessments (HTA)
  • FDA Guidance update, including EAP – regulatory review pathway
  • Subgroup analyses
Day 2 Therapeutic Track
  • Statistical challenges in recurrent events
  • Study design considerations, including non-randomized study design with historical control, PC/Performance Goal identification and justification (weighted OPC)
  • Multiplicity issues, including multi-region, multiple endpoints, repeated measures
  • Patient Report Outcome (PRO)/patient preference – case studies
Day 2 Diagnostics Track
  • Equivalence
  • Clinical studies
  • Study design considerations for new or different technologies
  • CLSI Guidance

Date and Location:

This meeting will be held on May 3-4, 2016 at the following location:

Renaissance Arlington Capital View Hotel
Arlington, VA


For questions regarding this workshop and content please contact: Stephanie Kinchen, Advanced Medical Technology Association, Medical Technology Learning Institute, 701 Pennsylvania Avenue, NW, Suite 800, Washington, DC; (202) 783-8700; (202) 783-8750 fax;

Page Last Updated: 02/07/2017
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