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DIA 2018 Global Annual Meeting


Harmonization Beyond ICH

    Session Chair(s)
      Camille  Jackson

      Camille Jackson

      • Senior Director, Science and Regulatory Advocacy
      • Pharmaceutical Research and Manufacturers of America (PhRMA), United States
    This forum will include representatives from ewmerging markets to discuss 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.
    Learning Objective : Describe the value and benefits of global regulatory harmonization and the ICH; Discuss opportunities to advance regulatory science through ICH; Identify the current harmonization initiatives that are currently underway and the impact on global drug development.
    Speaker(s)
      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
      Celia  Lourenco, PhD

      Panelist

      Celia Lourenco, PhD

      • Interim Senior Executive Director, Therapeutic Products Directorate
      • Health Canada, Canada
      Carol  Zhu, MBA

      Panelist

      Carol Zhu, MBA

      • Senior Vice President and Managing Director
      • DIA China, China