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

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

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: