A Message from the Co-Chairs of the FDA-Duke Global Regulatory Workshop

Welcome to this workshop!
Cancer remains a serious global health threat. Oncology drug development has continued to lead other therapeutic areas in addressing the highly unmet medical needs of the cancer patients and their treatment, attested by ever-increasing numbers of global oncology clinical trials. Therefore, speeding up the development and making drugs available as rapidly as possible to the patients are in the best interests of all stakeholders of oncology drug development. However, the approaches to do so vary around the globe.

In this context, FDA’s Oncology Center of Excellence (OCE) and Duke University convene this Global Regulatory Workshop to:

  • Provide a forum for international regulators to exchange their experience in oncology drug regulation/approval, discuss their regulatory priorities, challenges and opportunities in facilitating oncology drug development and approval;
  • Discuss the viewpoints from academicians and drug developers on many important issues related to global oncology drug development;
  • Discuss oncology drug development in China, recognizing the potential of the market in China; and
  • Provide perspectives from news media on the global drug development.

These topics are designed to enrich the experience of attendees and enable them to familiarize themselves with global regulatory framework. In addition, this workshop provides an opportunity for attendees to directly interact with regulators from international regulatory bodies and other stakeholders to foster global oncology drug development for benefiting patients with cancer in the United States and around the world. We look forward to your active participation in this workshop and sincerely hope that it will

provide you with useful information and contribute to the success of your current and future endeavors in oncology drug development and our fight against cancer.