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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
Sarah Golding, MD
Therapeutics Goods Administration, Australia
Senior Medical Officer - Oncology and Malignant Haematology Clinical Evaluation
Panelist - Brazil
Marcelo Moreira, MS
ANVISA, Brazil
GENERAL MANAGER
Panelist - Canada
Melissa Hunt, MSc
Health Canada, Canada
Director
Panelist - Israel
Michal Hirsh-Vexberg, PharmD
Israel Ministry of Health, Israel
Head of the Pharmaceuticals Registration Department, Medical Technology, Health
Panelist - Singapore
Representative Invited
Singapore HSA, Singapore
Panelist - Switzerland
Ulrich Peter Rohr, DrMed
Swissmedic, Switzerland
Unit Head Clinical Review Hematology & Oncology
Panelist - United Kingdom
Representative Invited
MHRA, United Kingdom
Panelist - United States
R. Angelo De Claro, MD
FDA, United States
Associate Director for Global Clinical Sciences, Oncology Center of Excellence
Panelist - United States
Dianne Spillman
FDA, United States
Associate Director, Global and Regulatory Outreach, OCE
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