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開催日: Jul 24, 2025

開催時間: 11am ET

関連ソリューション:Preclinical, Early Clinical, Late Clinical, Regulatory

関連ソフトウェア: Phoenixᵐᶜ

概要

A smarter, data-driven approach to QTc analysis can streamline your development timeline while minimizing costs and regulatory risk. Traditional strategies often rely on a one-size-fits-all solution—an approach that can either miss opportunities for simplified C-QTc analysis or underestimate the need for more robust analysis.

On the contrary, a stepwise strategy that begins with an exploratory concentration-QTc analysis can help chart a more efficient and cost-effective course. By pairing early insights into your data with program goals, you can determine whether to pursue a waiver, run a focused TQT analysis, or build a complex model only when truly necessary.

In this webinar, Certara experts will break down this approach and provide insight into how evolving regulatory expectations are shaping QTc evaluation

  • Patrick F. Smith, PharmD – SVP, Translational Science
  • Adekemi Taylor, PhD – VP, Regional Lead USA, Division 1, Quantitative Science Services
  • Kara Schmelzer, PhD – Sr. Director, Consulting

お申込みはこちら


You’ll gain a clear understanding of how exploratory analysis supports stronger decision-making, smoother regulatory submissions, and reduced downstream risk.

Whether you’re planning your first QTc analysis or reassessing your current strategy, don’t miss this chance to advance safety and your drug candidate.

Key Learning Objectives:

  • Understand the value of incorporating early ECG collection to facilitate exploratory C-QTc into development timelines which allows key cardiac safety decisions
  • Understand when and how to justify waivers, design focused TQT analysis, or build complex models
  • Gain insights into evolving regulatory expectations and how to align your QTc strategy accordingly
  • Discover how a tailored approach reduces unnecessary analysis and downstream risk

講演者

Patrick F. Smith, PharmD

SVP, Translational Science

Adekemi Taylor
Adekemi Taylor, PhD

VP, Regional Lead USA, Division 1, Quantitative Science Services

Kara Schmelzer, PhD

Sr. Director, Consulting

お申込みはこちら


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