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Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Authorized by the 21st Century Cures Act, the FDA’s Oncology Center of Excellent (OCE) is the first intra- center institute working across different functional areas of the agency. In the past two years, the OCE has launched more than 10 initiatives, ranging from promoting collaboration in cancer trial design and analysis to providing consistent review of safety signals across different drug classes. Among these diverse programs, several directly and immediately affect oncological drug development: Project Equity, Project Optimus, and Project Front Runner. Project Equity aims to enhance the diversity of clinical trial participants, while Project Optimus focuses on reframing the dose selection paradigm. Project Front Runner is part of an ongoing effort to reevaluate the accelerated approval pathway. It encourages sponsors to develop a comprehensive strategy to provide expedited access of innovative medicines to patients, while minimizing the period of uncertainty before clinical benefits of these therapeutics can be verified or refuted. Since approximately half of the approvals for cancer were through the accelerated pathway in the past decade, we are witnessing some of the most consequential changes in the oncological regulatory environment.
This webcast will provide an overview of these three programs and discuss their implications for oncological drug development. The goal is to help the audience better navigate the evolving regulatory landscape, which provides both challenges and opportunities.
1/19/2023 — 2/23/2023: Early Bird $150 Member | $175 Nonmember2/24/2023– 3/23/2023: Regular $175 Member | $200 Nonmember
At the conclusion of this workshop, participants should:
Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.
Regulatory affairs professionals working on oncology.
Program agenda, March 23, 2023, 12:00 am – 1:30 pm, ET
12:00 – 12:20 pm Dr. Vaibhav Kumar, CDER/FDA, Project Front Runner
12:20 – 12:40 pm Dr. Mirat Shah, CDER/FDA, Project Optimus
12:40 – 1:00 pm Dr. Jamie Brewer, CDER/FDA, Project Equity
1:00 – 1:30 pm Panel discussion
Vaibhav Kumar is a medical oncologist and a clinical reviewer in the Division of Oncology 3. He received his M.D. from Imperial College London and gained membership to the Royal College of Physicians of London prior to moving to the US. He completed his internal medicine residency and Master’s in Clinical and Translational Science from Tufts Medical Center.
Prior to joining the FDA in 2021, he completed his hematology and oncology fellowship at University of North Carolina at Chapel Hill. He specializes in the management of patients with gastrointestinal malignancies. His research focus lies in the development and validation of clinical risk prediction tools to personalize patient care. He has first author publications in the Annals of Internal Medicine, JAMA Oncology, Oncologist and Lancet.
Dr. Mirat ShahCDER/FDA, Project Optimus
Dr. Jamie BrewerCDER/FDA, Project Equity
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