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
