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  • Meeting the FDA for Orphan Products: Practical Strategies to
    Maximize Benefit

  • Hosted By:
  • ComplianceOnline
  • Start:
  • Thursday - May 09, 2013 10:00 AM
  • End Time:
  • Thursday - May 09, 2013 11:30 AM
  • Location:
  • Online
  • This training on orphan products will discuss FDA's guidance documents and the do’s and don’ts at FDA meetings for orphan products. It will explain proven techniques in preparing for FDA meetings using case-studies 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.

    Areas Covered in the Webinar:

    - 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
  • Website:
  • Visit the website for detail info

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