Meeting the FDA: How to get the best advice from the FDA -- ComplianceOnline-FDA Compliance Training (FDA Compliance Train)
|Event Date/Time: Nov 16, 2010||End Date/Time: Nov 16, 2010|
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 FDAâ€™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 donâ€™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.
FDAâ€™s review process and sponsor consultation.
Logistics of the FDA meeting.
Follow-up to an FDA meeting.
Doâ€™s and donâ€™ts of an FDA meeting.