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Harmonizing Regulatory Science Through the International Council for Harmonisation (ICH)
Session Chair(s)
Amanda Marie Roache, MS
Senior Director, Science and Regulatory Advocacy
Pharmaceutical Research and Manufacturers of America (PhRMA), United States
Since its inception in 1990, the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) has been unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug development, manufacture, and registration. ICH has gradually evolved to respond to the increasingly global face of medicines development and regulation, which included a set of reforms completed in 2015 designed to enhance its governance and sustainability, while opening its doors to new regulatory authorities and industry sector partners. While the ICH mission remains unchanged --- to achieve greater regulatory harmonization worldwide to ensure that safe, effective, and high quality medicines are developed and registered in the most resource-efficient manner --- the value of ICH continues to expand beyond the US, Europe, and Japan to further benefit patients, regulatory authorities, and industry around the globe through the development and maintenance of harmonized regulatory guidelines that help advance new regulatory science. This session will provide an overview of the ICH association and offer insight into current harmonization efforts including strategic, long-term views on advancing global convergence of regulatory science through ICH. A panel of experts will discuss the benefits of ICH and global harmonization, including views on key strategic topics that will enhance simultaneous global drug development.
Learning Objective : Recognize the value and benefits of global regulatory harmonization and the ICH; Discuss opportunities to advance regulatory science through ICH; Describe the current harmonization initiatives that are currently underway and the impact on global drug development.
Speaker(s)
Panelist
Theresa Mullin, PhD
FDA, United States
Associate Center Director - Strategic Initiatives, CDER
Panelist
Michelle Limoli, PharmD, RPh
FDA, United States
Senior International Health Science Advisor, Office of the Director, CBER
Panelist
Jerry Stewart, JD, MSc, RPh
Pfizer Inc, United States
Vice President Global Regulatory Policy and Intelligence, Global RA
Panelist
Toshiyoshi Tominaga, PhD
Keio University Hospital, Japan
Project Professor
Panelist
Celia Lourenco, PhD
Health Canada, Canada
Director General, Biologic and Radiopharmaceutical Drugs Directorate, HPFB
Panelist
Nicholas Cappuccino, PhD
Dr. Reddy's Laboratories, United States
Chair, IGBA Science Committee; Consultant, Compliance, Quality & Sci Affairs
Panelist
Wassim Nashabeh, PhD
Genentech, A Member of the Roche Group, United States
Vice President, Global Head of Technical Regulatory Policy & International Ops
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