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Project Orbis: Six Years Later
Session Chair(s)
Sema Hashemi, MSC
Senior International Policy Advisor, FDA, United States
In 2019, FDA’s OCE initiated Project Orbis to provide a framework for concurrent submission and review of oncology drug products. Project Orbis Partners will provide an update on their recent collaboration and answer questions from the audience.
Learning Objective : Discuss recent collaboration efforts beyond Project Orbis that were prompted by the initiative and explain how sponsors can benefit from participating in Project Orbis.
Speaker(s)
Panelist - Australia
Senior Medical Officer - Oncology and Malignant Haematology Clinical Evaluation , Therapeutics Goods Administration, Australia
Panelist - Brazil
GENERAL MANAGER, ANVISA, Brazil
Panelist - Canada
Director, Health Canada, Canada
Panelist - Israel
Head of the Pharmaceuticals Registration Department, Medical Technology, Health , Israel Ministry of Health, Israel
Panelist - Singapore
Regulatory Consultant/Clinical Lead, Health Products Regulation Grou, Singapore HSA, Singapore
Panelist - Switzerland
Unit Head Clinical Review Hematology & Oncology, Swissmedic, Switzerland
Panelist - United Kingdom
Interim Executive Director, Healthcare Quality and Access, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Panelist - United States
Deputy Director (Acting), Oncology Center of Excellence, FDA, United States
Panelist - United States
Associate Director, Global and Regulatory Outreach, OCE, FDA, United States
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