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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
Regulatory and Industry experts will reflect on progress on global regulatory harmonization of requirements for the development of medicines since the founding of ICH and it’s expanded global footprint following the reforms in 2015.
Learning Objective : Assess progress in global harmonization of regulatory requirements for the development of medicines since ICH reforms in 2015; Evaluate impact of specific ICH guidelines in global drug development such as E6(R2) Good Clinical Practice, E17 Multi-Regional Clinical Trials and M4Q(R2); Identify opportunities for greater regulatory harmonization to advance global drug development.
Speaker(s)
US Regulatory Perspective on the Future of International Harmonization
Representative Invited
FDA, United States
Industry Priorities for the Future of International Regulatory Harmonization
Wassim Nashabeh, PhD
Genentech, A Member of the Roche Group, United States
Vice President, Global Head of Technical Regulatory Policy & International Ops
EMA Perspective on ICH GCP Renovation and E6 Revision and Future Opportunities
Representative Invited
European Medicines Agency, Netherlands
ANVISA Perspective on International Global Harmonization and Future Opportunities
Marcelo Moreira, MS
ANVISA, Brazil
GENERAL MANAGER
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