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Orphan products have unique requirements for minimum testing to establish benefit to the target patients. An orphan product with significant improvement over available therapies or standard of care may be approved with much fewer clinical trials and minimal animal studies.
Since several orphan products may be the only treatment option available to patients, FDA provides considerable flexibility in terms of the number and size of animal and clinical studies required to secure their market approval. However, with very few guidance documents available, orphan product developers have to rely heavily on multiple discussions with the FDA all issues specific to their product. This seminar will discuss the various options available to orphan product developers at different times in the development pathway. Case studies will be used to highlight common mistakes and potential solutions.
Why Should you Attend:
Orphan products require special interactions with the FDA reviewers. Formal meetings with the reviewers not only provide an opportunity to the developers to discuss orphan product development strategies with the regulators but also help clarify issues as they arise. Unlike conventional products, orphan product developers usually require more interactions with the FDA due to special nature of the target indications. This webinar will discuss practical strategies for FDA meetings for orphan products to maximize the benefit to the sponsor in terms of faster time to market. The seminar will discuss the do’s and don’ts of FDA meetings describing common mistakes and possible solutions using real-life case studies. Techniques in preparing for FDA meetings, from the initial request to close-out of discussions post-meeting will be described.
Objectives of the Presentation:
Types of FDA meetings
Key guidelines available from FDA
Preparing the meeting request
Preparing for the actual meeting
FDA’s review process and sponsor consultation
Logistics of the FDA meeting
Follow-up to an FDA meeting
Do’s and don’ts of an FDA meeting
Who can Benefit:
This webinar will provide valuable assistance to:
Regulatory affairs professionals
Senior management executives (CEO, COO, CFO, etc)
Project Managers
Clinical trial specialists
Regulatory Compliance Associates and Managers
People investing in FDA-regulated product development projects
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