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DIA 2021 Global Annual Meeting


Global Regulatory Harmonization for Increased Patient Access to Medicines Through the International Council for Harmonisation (ICH)

Session Chair(s)

Amanda Marie Roache, MS

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)

Theresa  Mullin, PhD

ICH Multiyear Strategy and Future Vision

Theresa Mullin, PhD

  • Associate Director for Strategic Initiatives, CDER
  • FDA, United States
Si Yuan  Zhou

NMPA Perspective on ICH Progress and Future Approach

Si Yuan Zhou

  • Deputy Director of CDE, Head of ICH China Office
  • National Medical Products Adminsitration (NMPA), China
Gustavo  Mendes Lima Santos, MPharm

ANVISA Perspective on ICH and Recent Advancements in Brazil

Gustavo Mendes Lima Santos, MPharm

  • General Manager of Medicines and Biological Products
  • ANVISA, Brazil
Sharon  Olmstead

IFPMA’s Role in ICH and Future Outlook

Sharon Olmstead

  • Global Head, Regulatory & Development Policy
  • Novartis Pharmaceuticals Corporation, United States