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Harmonization Beyond ICH
Session Chair(s)
Camille Jackson
Director, Regulatory Policy; Legal and Regulatory
Flatiron Health , 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)
Panelist
Michelle Limoli, PHARMD, RPH
FDA, United States
Associate Director, International Programs
Panelist
Jerry Stewart, JD, MSC, RPH
Pfizer Inc, United States
Vice President Global Regulatory Policy and Intelligence, Global RA
Panelist
Angelika Joos, MPHARM
MSD, Belgium
Executive Director, Science & Regulatory Policy
Panelist
Celia Lourenco, PHD
Health Canada, Canada
Director General, Biologic and Radiopharmaceutical Drugs Directorate, HPFB
Panelist
Carol Zhu, MBA
JW Therapeutics, China
Vice President, Portfolio and Project Management