- May 13, 2021
12:00 PM - 1:00 PM ET
- Organized By:
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.
- Discuss the general framework of Project Orbis.
- Explain how other FDA and OCE review programs interact with Project Orbis.
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