In this free webinar, learn about the FDA Oncology Center of Excellence's special projects and programs. The featured speakers will discuss the focus on new dose optimization requirements through Project Optimus from a medical, scientific and operational perspective. Attendees will gain insights into the growing requirements for diversity, equity and inclusion among oncology clinical research. The speakers will also discuss innovative trial designs, methods of analysis and operational strategies to fulfill regulatory requirements.
TORONTO, Nov. 21, 2023 /PRNewswire-PRWeb/ -- Since 2017, the FDA's Oncology Center of Excellence (OCE) has created more than 300 research and educational outreach projects and programs focused on advancing the design, analysis, and regulations surrounding oncology drug development. As development continues to rapidly evolve, these projects and programs are intended to promote more effective and safer products, more accessible and efficient trials, and better patient outcomes.
These emerging programs will likely impact drug development efforts, potentially requiring lengthened timelines, greater enrollment and increased costs. In this webinar, Worldwide Clinical Trials' clinical research methodology and oncology strategy experts will present the OCE's most imperative initiatives. Attendees of this webinar will gain an understanding of multiple evolving projects at the OCE and how they impact your oncology program.
Key topics:
- The FDA Oncology Center of Excellence's special projects and programs
- A focus on new dose optimization requirements through Project Optimus from a medical, scientific and operational perspective
- Growing requirements for diversity, equity and inclusion among oncology clinical research
- Innovative trial designs, methods of analysis and operational strategies to fulfill regulatory requirements
Join experts from Worldwide Clinical Trials, Dr. Matt Cooper, Executive Director, Therapeutic Strategy Lead, Oncology; and Dr. Matthew Confeld, Assistant Director, Clinical Research Methodology, for the live webinar on Thursday, December 7, 2023, at 9:30am EST (3:30pm CET/EU-Central).
For more information, or to register for this event, visit FDA Oncology Center of Excellence: Programs & Projects That Impact Drug Development.
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