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10th Annual FDA/AdvaMed Medical Devices and Diagnostics Statistical Issues Conference

April 26, 2017 to April 27, 2017
Washington, DC
Diagnostics, Digital Health
Conference, Workshop

Join us to celebrate our 10th year of the Annual FDA-AdvaMed Medical Devices and Diagnostics Statistics Conference. This annual conference brings together leading authorities from FDA, industry and academia to address statistical topics through two tracks- therapeutic device and diagnostics.

    The reception following the first day of the conference will feature a poster session, co-hosted by AdvaMed and the American Statistical Association (ASA):

    • Posters due April 17 at 11:59 p.m. EST.  Submit posters to
    • Submit an electronic version of the poster (eg as .ppt or .pdf file)
    • Posters will be judged on statistical innovation, applicability to medical devices and diagnostics, clarity of presentation, effective use of graphics, appropriate example(s) used, and overall impression 

    Click here for more information and full details about the poster session.

    Please note there is a "Day 0" additional related workshop, co-hosted by AdvaMed and the American Statistical Association (ASA) Medical Device and Diagnostic Section, taking place the day prior to  this conference.  This year's Day 0 topic is Sample Size Calculations For Statistical Testing. Professionals often attend both the workshop and the conference.  Additional information and registration about this "Day 0" workshop can be found here.

    The 10th Annual Medical Devices and Diagnostics Statistics Conference is co-hosted with:


    Please click here to download the agenda

    Topics to be covered this year include:

    General Sessions 

    • Real world evidence (RWE)
    • Guidances
    • Effective FDA/Industry Communication 

    Therapeutic Track

    • Bayesian and Adaptive Designs 
    • Heterogeneity Issues in Clinical Trials
    • Statistical Challenges in Trial Design 1
    • Statistical Challenges in Trial Design 2 Related to Data Quality Improvement

    Diagnostic Track

    • In Vivo Diagnostics 
    • Analytical studies
    • Companion Diagnostics (CDx) 
    • Emerging technologies and precision medicine 

    Hotel & Meeting Logistics

    Washington Marriott at Metro Center
    775 12th St NW, Washington, DC 20005
    (202) 737-2200

    Room rate: $339.00
    Cutoff date for reservations: Monday, April 3, 2017
    Click here to reserve your room

    Registration Fees

    AdvaMed Accel Member Registration: $695.00

    AdvaMed Member Registration: $1,295.00

    FDA Registration: $250.00

    Non-Member Registration: $1,295.00

    Cancellation and Refund Policy
    All cancellations must be received via email to Cancellations received 10 business days or more prior to the start of the program are eligible for a full refund. There will be no refunds for cancellations received less than 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 us at with the substitute's registration information. All cancellation refunds will be processed within 30 business days from date cancellation request is received.

    Topics and speakers are subject to change without notice. AdvaMed reserves the right to cancel or reschedule any program, and the 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.