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International Regulatory Harmonization for Development of Medicines: A Look at How far We’ve Come and Where We Go From Here
Session Chair(s)
Amanda Roache, MS
Deputy Vice President, Science and Regulatory Advocacy , PhRMA, United States
The International Council for Harmonisation (ICH) was established in 1990 by regulatory authorities and industries in the United States, Japan, and Europe with a mission to harmonize requirements for the development of medicines. Since, the Association was reformed in 2015 to establish ICH as a true global entity, increase participation from regulatory authorities and industry around the world and increase the implementation of ICH guidelines globally thereby speeding access to medicines for patients and supporting the global supply of medicines. It has been nearly 10 years since the ICH reforms were completed. In this session, Regulatory and Industry experts will reflect on how far we’ve come and the progress achieved in harmonizing scientific and technical requirements for the development of medicines since 1990. Speakers will share perspectives on the evolution of medicines development as a result of ICH guideline development. Further, speakers will exchange perspective on future opportunities for international regulatory harmonization with consideration of the increasing globalized nature of medicines development and navigating the evolving landscape and use of innovative approaches before turning it over to the audience to hear their ideas around how to promote international harmonization and continued global drug development and patient access to medicines.
Learning Objective : Discuss progress in international harmonization of regulatory requirements for the development of medicines since ICH was established in 1990 and its increased global footprint following the reforms in 2015; Evaluate impact of ICH guidelines in global drug development; Identify future opportunities and how ICH can evolve to keep pace with innovation and further promote international regulatory harmonization and increased patient access to medicines.
Speaker(s)
Theresa Mullin, PhD
Associate Center Director - CDER, FDA, United States
US Regulatory Perspective on the Future of International Harmonization
Wassim Nashabeh, PhD
Vice President, Global Head of Technical Regulatory Policy & International Ops, Genentech, A Member of the Roche Group, United States
Industry Priorities for the Future of International Regulatory Harmonization
Marcelo Moreira, MS
GENERAL MANAGER, ANVISA, Brazil
ANVISA Perspective on International Global Harmonization and Future Opportunities
Peter Twomey, MA, MPharm
Head of Inspections, European Medicines Agency, Netherlands
EMA Perspective on ICH GCP Renovation and E6 Revision and Future Opportunities
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