ACRP 2024
About
Date/Time
Date(s) - May 3, 2024 - May 6, 2024 All DayLocation
Anaheim Marriott700 West Convention Way
Anaheim, CA 92802
NAMSA invites you to join us at ACRP 2024 on May 3-6 in Anaheim, CA. ACRP 2024 is the leading clinical research conference for gold-standard education and insights to boost your professional development—while ensuring quality and integrity in the clinical research process. ACRP will also connect you to the people and resources you need to be successful in clinical research. No other event offers more opportunities to share kinship, knowledge, and fun with your community.
Don’t miss NAMSA’s Wendy Schroeder (Principal Strategy Consultant, Clinical), who will be hosting a session titled “A Primer on the CMS Criteria for Approving Investigational Device Exemption Studies” on May 4 from 11:30a-12:30p. The session focuses on troubleshooting the “justifications” for the 10 approval criteria that matter most to CMS and learning more about what kinds of IDEs become winners.
Speaker
Wendy Schroeder
Principal Strategy Consultant, ClinicalWendy Schroeder has been involved with research and clinical trials for more than 25 years, and has a deep understanding of medical devices including in vitro diagnostics (IVDs) and companion diagnostics (CDx). She has served as a key company stakeholder in the implementation of an in-house contract research organization (CRO) infrastructure for a commercial laboratory moving bench IVD science into clinical validation studies and launching a biorepository of blood samples with annotated clinical data. Wendy has provided research operations oversight for commercial laboratories (Caris Life Sciences, Ashion Analytics) and IVD manufacturers (VisionGate, Inc.) as well as at hospital and clinical sites. She has supported medical device product development including device risk classification, pre-clinical testing and design controls and clinical strategy interactions with the FDA.
Wendy holds a Bachelor of Science in nursing degree from Arizona State University (Tempe, AZ). She is a certified Research Coordinator and Project Manager (ACRP) and a certified Research Contracts Professional (MAGI). She has been an invited speaker and author of peer-reviewed journal publications on molecular diagnostics (MDx), clinical trial billing and IVD/Laboratory Developed Test (LDT) regulatory matters.