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 Objectives
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.
Chair
Amanda Roache, MS
Speaker
US Regulatory Perspective on the Future of International Harmonization Theresa Mullin, PhD
Industry Priorities for the Future of International Regulatory Harmonization Wassim Nashabeh, PhD
ANVISA Perspective on International Global Harmonization and Future Opportunities Marcelo Moreira, MS
Pharmacist. At Anvisa, serving as General Manager of Biological Products, Radiopharmaceuticals, Blood, Tissues, Cells, Organs, and Advanced Therapy Products.
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 →
Vice President, Global Head of Technical Regulatory Policy & International Ops, Genentech, A Member of the Roche Group, United States
Dr. Wassim Nashabeh is the Vice President and Global Head of Regulatory Policy & International Operations for the Roche Pharmaceutical Group. In this capacity, Wassim has oversight of all technical outreach activities with global health authorities, industry associations and scientific... Read More →
Deputy Vice President, Science and Regulatory Advocacy, PhRMA, United States
Amanda Roache, MPP, is Deputy Vice President, Science and Regulatory Advocacy at the Pharmaceutical Research and Manufacturers of America (PhRMA). She leads PhRMA’s work under the International Council for Harmonisation (ICH) as well as key science and regulatory activities related... Read More →
Monday June 16, 2025 2:15pm - 3:15pm EDT TBDWalter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
