May 10 - May 12, 2021
11:00 AM-4:30 PM EST
New in this year’s virtual format, dedicated therapeutic and diagnostic-themed sessions will run on consecutive days, rather than concurrently as in years past. Attendees will have access to all therapeutic and diagnostic sessions across this three-day event. With daily networking receptions and breakout discussions, this conference provides the opportunity to meet and converse with peers, industry leaders, FDA representatives and more while forming lasting connections. Conference registrants who sign up before April 30 will save 15% on their registration fee.
AdvaMed Member registration: $975.00
AdvaMed Accel registration: $525.00
Government and Non-Profit registration: $250.00
Non-member registration: $1,200.00
AdvaMed member companies with 3 or more registrants of the conference may use the code STATSGROUP to save an additional 10% off the AdvaMed Member rate (Discounts must be applied at the time of registration).
Session Topics Include:
Dr. William Maisel, Chief Medical Officer and Director, Office of Product Evaluation and Quality, FDA/CDRH, will deliver a keynote address.
What's New in Medical Device Development
Hear about the re-organization in the office of clinical evidence and analysis (OCEA), new initiatives on external and real-world evidence issues, signal detection and methodologies to resolve current medical device issues.
External Evidence Methods Framework: Leveraging External Data in Therapeutic and Diagnostic Device Clinical Studies
This session will highlight the key aspects of the MDIC External Evidence Methods (EEM) framework, including traditional and novel statistical methodologies, and illustrate examples of how external data have been utilized in regulatory submissions.
Global Harmonization - International Regulations Impacting Statistical Practices
The need for collaboration across regions and the impact of recent regulatory changes on the level and type of evidence needed for device registration, approval, clearance or CE marking will be discussed.
Long-Term Safety Assessment
Session topics will include advantages and limitations of combining data from multiple sources using meta-analysis; feasibility of designing and conducting a clinical study for long term safety assessment; and advantages and challenges of using data from RCTs and observational studies for therapeutic devices.
Outcome-Free Study Design
This session will focus on the practical aspects of medical device trials leveraging external data from study design stage through the analysis process, including a case study.
Two-Phase Seamless Expedited Study Design
Speakers will discuss the use of a seamless two-phase design approach for acceleration of access to medical technologies specifically for treatment of seriously ill patients with unmet needs.
Clinical Outcome Assessment (COA)
This discussion will cover how to design and implement studies to capture the patient’s voice in a robust manner and may include methods, standards, and technologies to collect and analyze COA data for regulatory decision-making.
New Developments in Digital Health Involving Artificial Intelligence / Machine Learning
This session will provide an overview of recent developments in Digital Health technologies using AI/ML and the challenges and benefits of developing this technology. Speakers will examine statistical considerations of AI/ML methodology and the changing regulatory landscape.
Emerging Intended Uses for Diagnostic Devices, Risk Stratification, Workflow Prioritization and Shortened Reading Time
In this session, issues around study design and product validation including
New Trends and Statistical Challenges in Evaluating NGS, Liquid Biopsy and Tumor Profiling Technologies
This session will highlight and discuss related statistical issues and provide case examples for evaluating the performance of diagnostic tests and evaluating incremental changes to marketed diagnostic devices.
Analytical Study Issues: CLSI Guidelines Update and Establishing Performance Criterion
This session will provide an update on CLSI guidance, highlight some statistical issues in the analytical study validation and issues when setting performance criteria for analytical studies.