Project Orbis: What you need to know
Project Orbis is an initiative launched in 2019 by the Oncology Centre of Excellence at the FDA (US Food and Drug Administration). The goal of the initiative is to leverage the existing scientific and regulatory partnerships between international regulatory authorities to provide a framework for concurrent submission and review and facilitate faster patient access to innovative cancer therapies with a high medical need across multiple countries.
In this webinar our Senior Consultant and Project Orbis Lead, Claudia Reichle provides a closer look at Project Orbis and discusses what you should think about if you are offered the possibility to take part.
Fill out the form on the right to download this content.
Your drug development needs are unique
Contact us to learn how our experts can support you to meet all regulatory, quality and safety requirements and ensure the best path to approval.
Let's Bring Medicines to the World