Meeting the FDA: How to get the best advice from the FDA - ComplianceOnline FDA Training 2010

Understand how to prepare for FDA meeting before formally submitting the marketing application, what are do s and don ts and what are possible solutions for a successful FDA meeting.

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.

Who Will Benefit: This webinar will provide valuable assistance to all personnel in:

• 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