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Short Course Registration: 7:00-8:00AM

This short course will uncover the regulatory principles and guidances which are used by Health Canada statisticians as part of the overall review process. In addition, new statistical principles being explored as part of developing new clinical study designs will be discussed. Case studies will help the lay regulatory professional work through “thinking like a statistician.”

*Short Courses are not included in the meeting registration and require a separate fee.

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Learning objectives

At the conclusion of this short course, participants should be able to:

  • Describe the existing ICH statistical guidances as it relates to regulatory decision-making
  • Explain the role of the statistical review as part of the overall regulatory decision-making
  • Discuss how statistical approaches will need to evolve with evolving study designs (such as basket or umbrella trials)