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DIA 2018 Global Annual Meeting


Harmonizing Regulatory Science Through the International Council for Harmonisation (ICH)

    Session Chair(s)
      Amanda Marie Roache, MS

      Amanda Marie Roache, MS

      • Operations Research Analyst, OSP, CDER
      • FDA, 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)
      Theresa M. Mullin, PhD

      Panelist

      Theresa M. Mullin, PhD

      • Director, Office of Strategic Programs, CDER
      • FDA, United States
      C. Michelle  Limoli, PharmD

      Panelist

      C. Michelle Limoli, PharmD

      • Senior International Health Sciences Advisor, Office of the Director, CBER
      • FDA, United States
      Jerry  Stewart, JD, MS, RPh

      Panelist

      Jerry Stewart, JD, MS, RPh

      • Deputy Vice President, Scientific and Regulatory Advocacy
      • Pharmaceutical Research and Manufacturers of America (PhRMA), United States
      Toshiyoshi  Tominaga, PhD

      Panelist

      Toshiyoshi Tominaga, PhD

      • Associate Executive Director (for International Programs)
      • Pharmaceuticals and Medical Devices Agency (PMDA), Japan
      Celia  Lourenco, PhD

      Panelist

      Celia Lourenco, PhD

      • Interim Senior Executive Director, Therapeutic Products Directorate
      • Health Canada, Canada
      Nick  Cappuccino

      Panelist

      Nick Cappuccino

      • Chief Technical Officer and Scientific Advisor
      • Dr. Reddy's Laboratories, United States