ACRP 2018 Meeting & Expo


237 - Protocol Development for Device Studies: Optimizing Endpoint Selection for Maximizing Regulatory and Marketing Needs


Apr 29, 2018 3:30pm ‐ Apr 29, 2018 4:30pm


Credits: None available.

Members: $25.00
Standard: $75.00
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Description

Gain the tools you need to develop a protocol that meets regulatory and marketing needs through inquiries, surveys, and discussions. Developing device protocols that maximize impact while minimizing costs is difficult, and often does not reach the goal of generating data for both. Developing protocols that either meet the needs of both regulatory and marketing, or setting up post market studies that answer these questions, requires both detective and analytic capabilities. Speakers will shed light on the steps required to determine what data needs to be collected to answer these questions, or support the post market surveillance to do so.

Learning Objectives:

  • Determine what endpoints for Regulatory can do for Marketing
  • Developing strategies to collect data for marketing claims
  • Minimizing Sample size to answer both Regulatory and Marketing needs

Speaker(s):

  • Victor Chen, Director, Clinical Affairs, Align Technology
  • Christopher Cain, CCRA, RAC, VP, Clinical and Regulatory Affairs, Conformal Medical, Inc.

Credits Available


Protocol Development for Device Studies: Optimizing Endpoint Selection for Maximizing Regulatory and Marketing Needs

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