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Tuesday, June 29 • 2:00pm - 3:00pm
#246 SL: Global Regulatory Harmonization for Increased Patient Access to Medicines Through the International Council for Harmonisation (ICH)

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-581-L04-P; CME 1.00; IACET 1.00; RN 1.00

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 Objectives

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.


Amanda Marie Roache, MS


ICH Multiyear Strategy and Future Vision
Theresa Mullin, PhD

NMPA Perspective on ICH Progress and Future Approach
Si Yuan Zhou

ANVISA Perspective on ICH and Recent Advancements in Brazil
Gustavo Mendes Lima Santos, MPharm

IFPMA’s Role in ICH and Future Outlook
Sharon Olmstead

avatar for Amanda Roache

Amanda Roache

Senior Director, Science and Regulatory Advocacy, Pharmaceutical Research and Manufacturers of America (PhRMA), United States
Amanda Roache, MPP, is a Senior Director in PhRMA’s Science and Regulatory Advocacy Department. She leads PhRMA’s work under the International Council for Harmonisation (ICH) as well as key science and regulatory activities related to international regulatory policy, advocacy... Read More →
avatar for Theresa Mullin

Theresa Mullin

Associate Center Director - Strategic Initiatives, CDER, FDA, United States
Dr. Mullin is Associate Center Director for Strategic Initiatives. She leads various efforts including Patient-Focused Drug Development and CDER’s International Program. She leads the FDA delegation to ICH and currently chairs the ICH Management Committee. She led FDA negotiations... Read More →
avatar for Sharon Olmstead

Sharon Olmstead

Global Head, Regulatory & Development Policy, Novartis Pharmaceuticals Corporation, United States
Sharon Olmstead is the Global Head of Development & Regulatory Policy at Novartis. She first joined Novartis in 1997, in their FDA Liaison Office. From 2002 until returning to Novartis in 2011, she held leadership positions at Merck, Schering-Plough, and Pharmacia. She built a foundation... Read More →
avatar for Gustavo Mendes Lima Santos

Gustavo Mendes Lima Santos

General Manager of Medicines and Biological Products, ANVISA, Brazil
General Manager of Medicines and Biological Products at ANVISA, Brazil. Responsible for the management of drug and biological product registration submission evaluation teams, authorization to conduct clinical trials in Brazil, and certification of bioequivalence centers. I have been... Read More →

Si Yuan Zhou

Deputy Director of CDE, Head of ICH China Office, National Medical Products Adminsitration (NMPA), China
Mr. Zhou is the deputy director of the Center for Drug Evaluation (CDE), NMPA, China. He has been entitled in 2017 council member for Chinese Pharmaceutical Association and executive member for China Pharmacopoeia Commission. Mr. Zhou has 12-years’ clinical review experience, as... Read More →

Tuesday June 29, 2021 2:00pm - 3:00pm EDT
TBD Virtual Event Horsham, PA 19044
  09: Regulatory, Forum