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Global Perspective on ICH: Part 1 of 2
Session Chair(s)
Amanda Roache, MS
Deputy Vice President, Science and Regulatory Advocacy , PhRMA, United States
This forum will provide an overview of the ICH association and offer insight into strategic, long-term views on advancing global convergence of regulatory science through ICH, including important enablers such as stakeholder partnerships and greater connection to other harmonization initiatives. A panel of experts will discuss the benefits of ICH and global regulatory harmonization, including views on key strategic topics that will enhance simultaneous global drug development.
Learning Objective : Describe the structure of the ICH association, the process for developing a harmonized guideline, and the purpose for the recent reforms; Discuss ICH’s strategic approach in the selection of topics for guidance development; Explain the current state and the future trajectory of ICH; Discuss the value of ICH to regulatory authorities; Identify some of the areas of current ICH guideline development.
Speaker(s)
Toshiyoshi Tominaga, PHD
Life Science Department, Advisor, Sunflare, Japan
Regulatory Perspective on ICH
Cathy A. Parker
Director General, Biologics & Genetic Therapies Directorate HPFB, Health Canada, Canada
Recap of Recent ICH Meeting
Theresa Mullin, PHD
Associate Center Director - CDER, FDA, United States
Panelist
Gabriela Zenhaeusern, PHD
Head Stakeholder Engagement, Swissmedic, Switzerland
Panelist
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