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Project Orbis: Six Years Later
Session Chair(s)
Sema Hashemi, MS
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)
Sarah Golding, MD
Senior Medical Officer - Oncology and Malignant Haematology Clinical Evaluation , Therapeutics Goods Administration, Australia
Panelist - Australia
Marcelo Moreira, MS
GENERAL MANAGER, ANVISA, Brazil
Panelist - Brazil
Melissa Hunt, MSC
Director, Health Canada, Canada
Panelist - Canada
Michal Hirsh-Vexberg, PHARMD
Head of the Pharmaceuticals Registration Department, Medical Technology, Health , Israel Ministry of Health, Israel
Panelist - Israel
Anuradha Poonepalli, PHD
Regulatory Consultant/Clinical Lead, Health Products Regulation Grou, Singapore HSA, Singapore
Panelist - Singapore
Ulrich Peter Rohr, DrMed
Unit Head Clinical Review Hematology & Oncology, Swissmedic, Switzerland
Panelist - Switzerland
Julian Beach, MBA
Interim Executive Director, Healthcare Quality and Access, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Panelist - United Kingdom
R. Angelo De Claro, MD
Deputy Director (Acting), Oncology Center of Excellence, FDA, United States
Panelist - United States
Dianne Spillman
Associate Director, Global and Regulatory Outreach, OCE, FDA, United States
Panelist - United States
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