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Global Perspective on ICH: Part 1 of 2
Session Chair(s)
Amanda Marie Roache, MS
Senior Director, Science and Regulatory Advocacy
Pharmaceutical Research and Manufacturers of America (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)
Regulatory Perspective on ICH
Toshiyoshi Tominaga, PhD
Keio University Hospital, Japan
Project Professor
Recap of Recent ICH Meeting
Cathy A. Parker
Health Canada, Canada
Director General, Biologics & Genetic Therapies Directorate HPFB
Panelist
Theresa Mullin, PhD
FDA, United States
Associate Center Director - Strategic Initiatives, CDER
Panelist
Gabriela Zenhaeusern, PhD
Swissmedic, Switzerland
Deputy Head Stakeholder Engagement
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