Meeting the FDA: How to get the best advice from the FDA -- ComplianceOnline-FDA Compliance Training (FDA Compliance Train)

Venue: OnlineEvent

Location: Palo Alto, California, United States

Event Date/Time: Nov 16, 2010 End Date/Time: Nov 16, 2010
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Why Should You Attend:

The ultimate goal of any product development is successful approval by the FDA. Since FDA makes the final decision if the information provided in a given marketing application is sufficient to approve or reject, it makes a lot of sense to discuss the contents with the FDA reviewer prior to submitting the formal application and FDA encourages it so that sponsors can become aware of FDA’s concerns and it will help the applicant trouble-shoot issues before formal submission of data.

Periodic and timely discussions with the FDA have been shown to exponentially increase the probability of the rapid market approval for a given product. The webinar training will discuss the dos 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. Attend this webinar to learning how to make the most of meetings with FDA to achieve timely and cost-effective product development.

Areas Covered in the Seminar:
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.


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