Project Orbis: Global Collaborative Oncology Review Program
FDA Oncology Center of Excellence (OCE) launched Project Orbis in May 2019 with international regulatory authorities as a global collaborative review program for oncology marketing applications. Current Project Orbis partners include the regulatory health authorities of Australia, Brazil, Canada, Singapore, Switzerland, and the United Kingdom. The program aims to facilitate the submission, review, and approval of high-impact oncology marketing applications across the participating countries. Read more here. Register for the webcast here.
Learning Objectives: Discuss the general framework of Project Orbis, and explain how other FDA and OCE review programs interact with Project Orbis.
Date/time: 13th May 2021 at 12:00 pm – 1:00 pm EST