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As combination products become an increasingly important component of the pharmaceutical product portfolio, building a strong scientific bridge for the drug and/or device constituent part is vital. Indeed, the recently passed 21st Century Cures Act contains new statutory provisions aimed at facilitating the use of already-approved components in novel combination products, and in PDUFA VI, the FDA has agreed to issue guidance on bridging studies.
In this one-day workshop, participants will learn from regulators and industry representatives the key considerations for comparability bridging studies for the drug and device components for combination products.Through presentations, panel discussions, and group break-out sessions, participants will learn the importance of a risk-based bridging approach and the challenges/opportunities in executing robust product development plans that expeditiously deliver new therapeutic products to the patients who need them. The workshop will examine the multi-discipline testing approaches and opportunities for leveraging prior experience for an established drug or device constituent part in combination with a new drug/device. In an interactive break-out session, attendees will also analyze thought-provoking case studies based on real-life scenarios to stimulate discussion and identify the concerns, challenges and opportunities.
During this workshop, you will learn:
- Why is comparability bridging a necessary aspect of combination product development
- What are the current bridging study requirements and expectations
- What challenges are currently being faced in bridging
- The array of testing strategies and study tools available in the demonstration of comparability
- Use of leveraging prior experience for an established drug/device constituent parts
- Real-life case study examples that highlight and draw out the opportunities with bridging
- Considerations informing implementation of 21st Century Cures and PDUFA VI requirements
Please join us for this interactive one-day, open dialog workshop that will stimulate comparability bridging opportunities and help in the planning and execution of development plans for your combination products.