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  5. Project Orbis: Global Collaborative Oncology Review Program - 05/13/2021 - 05/13/2021
  1. FDA Grand Rounds


Event Title
Project Orbis: Global Collaborative Oncology Review Program
May 13, 2021

May 13, 2021
12:00 PM - 1:00 PM ET

About the Speaker:

R. Angelo de Claro, MD
Associate Director (Acting) for Global Clinical Sciences
U.S. FDA Oncology Center of Excellence

Dr. de Claro is a hematologist-oncologist with 11 years of FDA experience. He leads OCE efforts to advance cancer drug development and regulatory science across the globe, including direction of Project Orbis. He is also Director for Division of Hematologic Malignancies I, within the Office of Oncologic Diseases/Office of New Drugs/ Center for Drug Evaluation and Research (CDER).

About the Presentation:

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.

Learning Objectives:

  • Discuss the general framework of Project Orbis.
  • Explain how other FDA and OCE review programs interact with Project Orbis.

To Register:

FDA Employees


Webcast Registration: To register for the webcast, please click the link below and then follow the instructions on the registration page. After registration, you will receive a link via email to access the live webinar. You must log in with the username and password created when you registered. Please pre-register at least one day before the event to ensure you receive the access link email and outlook invitation for the session.


For technical assistance please contact Niccole.Corbin@fda.hhs.gov.


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