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Project Orbis: Six Years Later
Session Chair(s)
Sema Hashemi, MSc
Senior International Policy Advisor, OGPS, OC
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 : Provide an international regulatory update on Project Orbis; Discuss recent collaboration efforts beyond Project Orbis that were prompted by the initiative; Explain how sponsors can benefit from participating in Project Orbis.
Speaker(s)
Panelist
Sarah Golding, MD
Therapeutics Goods Administration, Australia
Senior Medical Officer - Oncology and Malignant Haematology Clinical Evaluation
ANVISA Perspective
Marcelo Moreira, MS
ANVISA, Brazil
GENERAL MANAGER
Panelist
Representative Invited
Health Canada, Canada
Panelist
Michal Hirsh-Vexberg, PharmD
Israel Ministry of Health, Israel
Head of the Pharmaceuticals Registration Department, Medical Technology, Health
Panelist
Representative Invited
FDA, United States
Panelist
Representative Invited
FDA, United States
Panelist
Representative Invited
MHRA, United Kingdom
Panelist
Ulrich Rohr
Swissmedic, Switzerland
Unit Head Clinical Review
Panelist
Representative Invited
Singapore HSA, Singapore
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