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Global Regulatory Harmonization for Increased Patient Access to Medicines 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
Leaders in global pharmaceutical development and regulation will convene to share views on the latest advancements under ICH, including new areas of work, and to discuss areas of emerging importance and ICH’s thinking around a multi-year strategy. There will also be discussion of the role of ICH guidelines during the COVID-19 pandemic and any related learnings for regulatory science and possible future ICH harmonization.
Learning Objective : Discuss progress in the harmonization of regional requirements for the development and manufacture of pharmaceuticals; Describe ICH’s multi-year strategy and areas that will be important for global alignment in the years to come; Identify ICH’s role in responding to the global pandemic and any opportunities for learnings to be addressed in ICH guidelines.
Speaker(s)
ICH Multiyear Strategy and Future Vision
Theresa Mullin, PhD
FDA, United States
Associate Center Director - Strategic Initiatives, CDER
NMPA Perspective on ICH Progress and Future Approach
Si Yuan Zhou
National Medical Products Adminsitration (NMPA), China
Director of CDE, Head of ICH China Office
ANVISA Perspective on ICH and Recent Advancements in Brazil
Gustavo Mendes Lima Santos, MPharm
Brazilian Health Regulatory Agency (ANVISA), Brazil
Herbal and Complementary Medicines Office - GMESP
IFPMA’s Role in ICH and Future Outlook
Sharon Olmstead
Novartis Pharmaceuticals Corporation, United States
Global Head, Regulatory & Development Policy
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