Dear JSM Attendees,
The Section on Medical Devices and Diagnostics is excited to sponsor our first-ever JSM roundtable lunches! Enjoy a small group discussion on an interesting topic and don't worry about where to eat, who to eat with, or getting back in time for a 2:00pm session.
Tuesday (TL19): Beimar Iriarte from Abbott Laboratories will lead "Design Specifications of Performance for an Analytical Laboratory Method." What is an acceptable margin of equivalence when comparing two laboratory tests? How does one evaluate bias, imprecision, and total error? Discuss these questions and related analysis methodologies with other people facing these challenges.
Wednesday (WL18): Theodore (Ted) Lystig from Medtronic, Inc. will lead "Considerations in Transitioning from Proprietary to Non-Proprietary Statistical Software to Support Regulatory Submissions." Using software such as R and OpenBUGS can play to the strengths of recent graduates and provide confidence in results obtained from different programs – but what about 21 CFR Part 11 Compliance, and validation? Share your thoughts.
Take an informal opportunity to learn, socialize, and network at one or both of these lunches. Looking forward to seeing you in Baltimore!
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Alicia Toledano
President
Biostatistics Consulting, LLC
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