International Regulatory Strategy: Impact of ORBIS

2:15 PM - 3:15 PM (PDT), Monday, June 13, 2022

ORBIS has demonstrated success and seems to function as a forum for other global regulators to leverage the FDA review. Participation in ORBIS may not always result in accelerated review timelines at collaborating agencies. However, project ORBIS is increasing review efficiency. This session will review the experiences gained by ORBIS participating partners highlighting lessons learned to enable future improvements. Regulators from FDA and selected countries will be invited to give testimonials on how they facilitated and supported ORBIS for their national registrations. Developers will review specific case studies from ORBIS collaborative reviews and their impact on international registrations in participating countries. We will identify factors to successfully engage in the project and highlight some challenges that might occur. The initial experiences can be used to optimize international registrations and speed access to livesaving oncology treatments.

Vice President, Oncology and In-Vitro Diagnostics, Global Regulatory Affairs and Safety
Merck & Co. Inc.
Associate Director (Acting) for Global Clinical Sciences
US FDA Oncology Center of Excellence (OCE)
of Director of the Bureau of Metabolism, Oncology and Reproductive Sciences within the Pharmaceutical Drugs Directorate
Health Canada
General Manager of Medicines and Biological Products
Agência Nacional de Vigilância Sanitária – ANVISA